Director, Safety Resume Samples

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B Goldner

Benedict

Goldner

6698 Stroman Field

Phoenix

+1 (555) 521 0917

6698 Stroman Field

Phoenix

Phone

p +1 (555) 521 0917

Experience Experience

Phoenix, AZ

Director, Safety

Phoenix, AZ

Weimann, Mitchell and Jerde

Phoenix, AZ

Director, Safety

Proven record of influencing key decision makers at an executive level regarding safety strategies
This position will be performed at the assigned operating company facilities
Facilitate the completion of a company-wide annual HSE training plan
Provide supervisor and management training on root cause analysis
Lead incident investigation process, including cause analysis and identification of corrective action plans
Develop and implement training programs to transfer HSE knowledge and core competencies to management and associates
Proven integrator that uses synergistic approach to problem solving, analysis, metrics and prevention

Los Angeles, CA

Director, Safety Scientists

Los Angeles, CA

Stamm-Larkin

Los Angeles, CA

Director, Safety Scientists

Provide support for Safety Signaling activities for Mallinckrodt Pharmaceuticals driving updates to safety information as determined necessary
Administer company incentive programs and performance management for the team
Build a team of Safety Scientists and lead career development and training initiatives for the team
Support Company Core Data Sheet development, review and updates
Contribute to the development of strategy and project plan for the integration of newly acquired pharmaceutical products into the Mallinckrodt Pharmacovigilance System
Lead organizational initiatives to drive Global excellence in PV and continuous process improvement
Support maintenance of the drug safety database and assist with configuration changes

present

Detroit, MI

Director, Safety & Security

Detroit, MI

Watsica-Ondricka

present

Detroit, MI

Director, Safety & Security

present

Extensive knowledge of the security field, including corporate policies and practices related to physical security; executive and personnel protection; investigations; loss and incident reporting/analysis; risk and threat assessment/analysis; health and safety, major incident management planning and response; guard force operations and management; and integration of security into business operations
Oversee the analysis of complex data and preparation of reports on safety and security activities including trends and recommended remediation and prevention strategies
Oversee development and approve departmental budget
Review management / supervisor level applicants for Safety and Security Department positions and select best candidates
Assist in developing capital budgets for fire safety and security
Oversee the development of comprehensive safety and security hospital-wide training and chair the Safety Education Workgroup of the EOC Subcommittee
Serve as institutional resource related to safety and serve on committees/groups in this capacity for the UIHC and UI

Education Education

Bachelor’s Degree in Safety

The University of Kansas

Bachelor’s Degree in Safety

Skills Skills

The ability to drive a strong safety philosophy and implement constructive behavior changes in transportation safety
Demonstrated knowledge of spreadsheet and word processing software, and ability to learn Sysco technology software and programs
Excellent employee relations and interpersonal communication skills; ability to interact effectively with all levels of management, supervision and employees
Demonstrate excellent verbal communication, written communication, and presentation skills
Excellent analytical skills
Leadership and team building skills, able to influence decision makers
Strong background in safety with a proven record of results
Other pertinent safety certification or designations are desirable as well
The ability to analyze and independently solve a variety of difficult situations and problems
Effectively using time and resources to accomplish overall initiatives and program goals

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15 Director, Safety resume templates

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Director Safety &toxicology Resume Examples & Samples

Raw Material safety review and support of the Third Party Manufacturing/Outside Vendor (TPM/OV) projects
Safety support and facilitate integration of new ELC acquisitions into ELC processes and standards
Work closely with teams supporting outside vendor process and maintain safety standards to meet regulatory and ELC requirements
Monitor outside vendor raw material safety/toxicology/regulatory issues. Reviews, summarizes, and presents critical issues to Product Safety & Toxicology team on regular basis
Serves as an expert in safety related issues to support ELC global operations. Performs comprehensive global safety, toxicological and regulatory reviews of raw materials for personal care products in ELC. Provides technical/toxicological advice to ELC staff, to raw material vendors, and to subcontractors
Reviews and coordinates safety testing of third party raw materials and finished products during integration or new product development phases
Masters or Ph.D. (Consumer, Food, Drug. Chemical, and/or General Toxicology), with 5 years of Personal Care Product experience, required
DABT, ERT, or EU Safety assessor, a plus
Familiar with risk assessment methodologies

Director, Safety Programs Resume Examples & Samples

Develop and implement cutting-edge programs to ensure safety and compliance. Establish priorities to achieve these strategies
Interface with senior executive leaders, develop and implement complex safety programs, and leverage industry programs and benchmark practices
Align programs worldwide through collaboration with site safety and operations executives, alignment of goals, objectives, standards and best practices across departments, removal of barriers, and consistency in safety communications
Influence, inspire commitment, solve complex problems, and thrive under a fast paced, high intensity, workload
Lead and develop a team of technical professionals
Evaluate site safety performance to determine best practices and then choose the best methods to document, train and measure effectiveness of programs
Interpret regulatory standards and evaluate site needs to develop and publish technical programs, project-manage scopes of work and determine capital investments to meet program goals
Act as a service provider to site Safety executives in addressing their programmatic needs
Proven integrator that uses synergistic approach to problem solving, analysis, metrics and prevention
Proven record of savvy business judgment along with the mental agility and flexibility required in a dynamic company
Proven ability to manage multiple priorities in a fast-paced multi-cultural environment with minimal direction
Possess unquestioned ethics and integrity
Proven experience interfacing with regulatory agencies
Bilingual language skills
International experience

Director, Safety Resume Examples & Samples

Develop and implement cutting-edge strategies for sustaining and evolving a world-class safety culture at Disneyland Resort. Establish priorities to achieve these strategies
Interface with senior executive leaders, lead cultural, and behavioral change, develop and implement complex safety programs, and leverage industry programs and benchmark practices
Provide oversight of day-to-day safety, including collaboration with site operations executives, alignment of goals, objectives, standards and best practices across departments, removal of barriers, leveraging of resources, and consistency in safety communications
Lead and develop a large team of technical professionals
Collaborate and support clients in disciplines which include but aren’t limited to: attractions operations, entertainment, merchandising, food and beverage, catering & conventions, housekeeping, transportation, horticulture, security, custodial, engineering, maintenance & manufacturing, construction, textile services, distribution services, utilities, pyrotechnics and animal programs
Minimum of 15 years progressive leadership experience in safety with a strong knowledge of OSHA regulations
Proven ability to develop strategies and drive financial results as it relates to implementation of safety practices, initiatives, and programs
Proven record of influencing key decision makers at an executive level regarding safety strategies
Demonstrated leadership skills with the ability to define a clear vision, motivate others in a positive way to achieve desired results and develop a successful team
Proactive communicator and relater who can interface effectively at all levels in the company and can appropriately influence business results through negotiation, persuasion and personal presence
Demonstrated strong consultative and influencing skills with proven ability to resolve conflicts and diffuse difficult situations
Demonstrated ability to leverage analytics and identify trends
Proven ability to benchmark both internally and externally to achieve best practices
Proven experience managing large operating budgets
Demonstrated compassion and commitment to diversity and inclusion including inviting diverse perspectives, fostering an inclusive work environment and supporting workforce diversity
Willingness and flexibility for domestic and occasional international travel
Proven success reducing incident rates and improving culture

Director, Safety Resume Examples & Samples

Monitors Worker's Compensation, auto liability and general liability claims and acts as a liaison to insurance carriers, local management, Corporate Risk Management, benefits, injured employees and medical providers
Ensures compliance with EHS audit, inspection and risk assessment processes. Reviews and analyze EHS audit results to confirm that corporate, business, and government standards are met
Participate in relevant external EHS professional business and industry organizations such as the American Society of Safety Engineers
Develops and implements recognition programs with Division teams to acknowledge positive behavior and celebrate successes for EHS achievements
Travel may include intrastate, within Region and outside of Region up to 70%
Develops plans to meet unexpected situations, new developments and changes in the business environment; prepares for emergencies; anticipates events; understands the factors and conditions affecting the organization and respond appropriately when these change
Monitors Worker's Compensation, general liability, claims and acts as a liaison to insurance carriers, local management, Corporate Risk Management, benefits, injured employees and medical providers

IT Director, Safety Execution & Delivery PLO Resume Examples & Samples

Bachelor’s degree and a minimum of 15 years of relevant experience OR advanced degree and a minimum of 12 years of relevant experience is required
Strong business process knowledge in Safety/Pharmacovigilance, and a demonstrated capability to apply technology solutions in addressing complex, global business issues. i.e. (Oracle Argus Safety, Aris Global ARISg) is required
Experience managing a team of consultant resources and companies, and internal and external technical personnel in a fast-paced, complex, global project environment is required
Experience managing global business priorities and projects across multiple business areas is required
Demonstrated project management capability based on the successful completion of large projects in global, cross-functional business area is required
Broad technology experience with ability to lead assessments of proposed solutions and develop recommendations is preferred
Understanding of the business impact of different solutions and ability to assess impact and communicate the tradeoffs between business needs, technology requirements, timelines, costs and risks is required
Understanding of departmental budgets and the ability to allocate resources accordingly is required
Thorough understanding of SDLC including requirements elicitation, system design, development and validation/regulatory requirements is required.Info Technology

Assistant to the Director, Safety & Security Resume Examples & Samples

Positively represent the Safety and Security department to Pixar employees, contractors and guests
Book all travel and create detailed itineraries
Help coordinate studio events including screenings and presentations, marketing summits and other events
Work with a variety of business partners (vendors, contractors, safety and security colleagues and associations) to schedule repairs, meetings and events
Coordinate logistics for on and off-site meetings, social events and team building events
Monitor and assign tasks within the work request system
Manage and reconcile American Express account, expense reports, purchase requisitions and orders, invoices and receipts, and flag upcoming expenses for budgetary purposes
Proactively manage all pertinent Safety and Security team calendar(s)
Take minutes at meetings and prepare reports for attendees
Organize and maintain metrics, including formulas for briefings and reports
Protect sensitive and confidential information
Coordinate and prepare domestic and international travel arrangements
Establish a positive rapport with other assistants, department managers, and studio leadership
Actively participate in the assistants’ community
Serve as backup for security functions (such as Reception), creating access badges and other duties as assigned
Manage day to day tasks and operations, which may include but are not limited to
Three to five years administrative experience supporting a dynamic and demanding office environment required, film industry experience preferred
Strong ability to work within ambiguous environments, adaptable to ever changing circumstances, situations and people
Demonstrated independent judgment and decision making skills
High levels of service for both internal and external customers, professionalism, focus, punctuality and reliability
Consistent and regular follow through on all requests
Ability to prioritize multiple requests and projects in fast paced deadline driven environment
Ability to resolve problems on the fly, creatively and resourcefully
An engaged team player, willing to collaborate and jump in to help
Initiative to learn new skills, studio procedures, and pipeline through self and studio education
Proficient in Microsoft Office; Wiki, Keynote, Filemaker Pro, cloud based services, video conferencing services, email and calendaring programs, and a quick learner of new applications; familiar with both Mac and PC

Senior Director, Safety & Health Resume Examples & Samples

Bachelor’s degree in safety or related field
Minimum of 12 years of progressive experience in Safety and/or Health in a complex, multi-billion dollar, industrial business environment
MBA or health related Master’s degree
Professional safety certification (e.g. certified safety professional, certified industrial hygienist)
Experience running a safety and health program or a leader in process safety
Experience in working with both union and management employees, particularly those working in large geographically dispersed field positions
Demonstrated experience in managing large geographically dispersed teams
A leader with keen analytic acumen, able to identify issues and opportunities for safety and health improvement from company-wide performance data
An individual possessing the leadership courage and the highest standards of ethics and integrity to identify safety-related issues and problems, and share them with senior management
A results-oriented leader with a strong sense of accountability
An excellent communicator, who can articulate the company's values, focus, and progress around safety to internal and external audiences
An individual who can build effective relationships and is skilled at forging alignment, relationships, and communication across the organization and with external entities, including unions and regulatory agencies
A highly organized professional who can deliver on multiple priorities, delve into detail where necessary, and maintain focus on the big picture
A leader who consistently demonstrates a commitment to the success and development of their team
A leader who lives and demonstrates the company's values around safety at work and at home, for both employees and the public

Assistant Director, Safety Management Resume Examples & Samples

Responsible for compliance with applicable Corporate and Divisional Policies and procedures
Manages, leads and develops staff across assigned therapeutic area(s) within Safety Management. Manages team activities to ensure compliance with regulations and guidelines
Assists in the identification, initiation and implementation of process and workflow procedure improvements. Monitors and communicates workload projections and metrics for respective therapeutic areas and participates in area budget process and proposals
Functions as a resource within Safety Management, Clinical Teams, and the larger organization
Provides guidance to staff on regulations and their impact on Safety Management processes and procedures. Knowledge of industry trends and processes
Facilitates department and divisional training programs, ongoing knowledge attainment, and development of staff throughout (GPRD) Global Pharmaceutical Research Division
Effectively identifies staff and department needs. Translates business vision into broad and actionable strategy. Successfully presents these to management when applicable. May assist management with strategic planning and department/division development
Knowledgeable of department strategic objectives and goals and facilitates incorporation of appropriate activities into therapeutic area teams activities and projects
Knowledgeable on Industry Best Practices in Clinical Trial Safety; assists with development of clinical safety policy and drives process improvement initiatives and implementation within assigned therapeutic areas; ensures application of clinical (SOPs) Standard Operating Procedures reflecting evolving global regulations and processes related to clinical trials are implemented within assigned teams; ensure clinical SOPs are being followed within assigned teams
Assists in the development of staffing model for Safety organization within Development Operations; implements standardized clinical safety training and performance assessments; provides change leadership for technology and process improvements
Safety Management representative/lead for cross functional committee(s); May assist in the review and provide clinical comment to draft regulatory guidances; participates in audit responses to regulatory agencies

Associate Director, Safety Statistics Resume Examples & Samples

Primary author of the Product Safety Statistical Analysis Plan (including Benefit Risk planning) and Integrated Summary of Safety Statistical Analysis Plan. Assure alignment of the PSSAP with the PSP, PBRER, DSUR, IB, and RMP
Active participant in Benefit-Risk value tree creation/discussion and responsible for the appropriate BR analyses (Benefit Risk Product Assessment and relevant submission documents)
Provide specs on how the data should be integrated across studies in accordance with the PSSAP/specifications provided to statistical programming and ensure appropriate analyses and interpretation for PBRER/DSUR/IB/RMP/Regulatory Requests, signal evaluations and Safety Summary for NDA/BLA/Other Regulatory Activities
Understand and support the use of safety graphics for ongoing safety review (JReview and other relevant tools) and appropriate inclusion in safety submission documents noted above
MS/PhD in Statistics, Biostatistics or related field. Minimum 8 years of experience (PhD) or 12 years (MS) is required
Advanced knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development
Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience
Substantive interactions with regulatory authorities preferred

Associate Director, Safety Epidemiology Resume Examples & Samples

Three (3) years pharmaceutical industry experience
Business or Epidemiologics analytics experience
In-depth knowledge of content and methods of epidemiology
Understanding of the product development process
Analytic skills as applied to epidemiologic research activities

Director, Safety Scientists Resume Examples & Samples

Build a team of Safety Scientists and lead career development and training initiatives for the team
Monitor the safety profile of Mallinckrodt investigational and marketed products by directing the analysis of safety data and preparation of aggregate safety reports (i.e. PSURs, PBRERs, DSURs), safety signaling reports, health hazard evaluations and other reports as required by Regulatory Authorities and safety partners
Assign Safety Scientists personnel to projects and project teams and ensure that projects are adequately staffed to meet project and regulatory timelines
Provide oversight for development and analysis of aggregate safety reports as well as drive collaboration with Regulatory Affairs for on time submission to Regulatory Authorities
Ensure the development and maintenance of processes, training and procedures to meet global safety reporting requirements for all projects handled by Safety Scientists
Develop and maintain a quality control process for all reports prepared by the Safety Scientists
Contribute to the development of strategy and project plan for the integration of newly acquired pharmaceutical products into the Mallinckrodt Pharmacovigilance System
Participate in due diligence activities
Represent PV in cross-functional organizational and alliance partner forums as needed
Collaborate with Global Safety Leads to ensure accurate and timely safety report assessments
Provide support for Safety Signaling activities for Mallinckrodt Pharmaceuticals driving updates to safety information as determined necessary
Support Company Core Data Sheet development, review and updates
Manage RMP deliverables and updates
Serve as internal Subject Matter Expert on relevant PV regulations and guidances, including those promulgated by the FDA, ICH and CIOMS
Ensure compliance of Safety Scientists with corporate procedures relative to PV
Develop and monitor metrics for compliance, quality and productivity
Support maintenance of the drug safety database and assist with configuration changes
Contribute to internal or external inspections and audits for PV
Lead organizational initiatives to drive Global excellence in PV and continuous process improvement
Define requirements of department personnel and work with Human Resources to hire such personnel
Administer company incentive programs and performance management for the team
Responsible for Safety Scientist department budget oversight
Attending seminars on global Drug Safety and Pharmacovigilance

Director, Safety Informatics Resume Examples & Samples

Minimum 10+ years of Pharmacovigilance / Drug Safety and Information Systems experience in the biopharmaceutical industry or equivalent required. Both pre-approval and post-marketing experience in a global environment highly desired
Bachelor’s level degree in computer science, life sciences, or equivalent work experience. Advanced degree desirable
Expertise in MedDRA and WHO-DD coding dictionary maintenance and use
Extensive experience as subject matter expert with software-based drug safety systems required, direct experience with ARGUS highly desired
Expert in safety business practices, as well as the translation of business into technical specifications on safety matters
Expert understanding of the technical requirements to implement a signal detection and pharmacovigilance program
Extensive experience in creating computer system validation deliverables (i.e., specifications, protocols, and reports), system lifecycle management, as well as extensive experience in executing protocols and test scripts
Experience with preparation of clinical/regulatory documents, as well as knowledge of relevant FDA, EU and ICH guidelines
Proven track record of leadership and ability to lead cross functional teams including IT, biometrics, regulatory, as well as external vendors/partners/CRO’s
Well-developed people management, time and project management, communication, presentation, analytical and interpersonal skills

Director, Safety & Pharmacovigilance Europe Resume Examples & Samples

Responsible for the design and implementation of life-cycle PVG services, including gap analysis to determine direction for INC Research in support of PVG systems
Special emphasis on working with clients navigating the change from clinical development into the post-approval environment
Developing and supporting education across the INC Research organization with respect to post-approval PVG
Collaboration with INC Research Business Development to educate, lead and develop customer relations, business development and the marketing of PVG services
Provide an intense level of support to all aspects related to the development of a PVG life-cycle activity, collaborating with INC Consulting, Medical Writing and Late Phase services at INC
Supporting audits/inspections
Draft, negotiate and execute SDEAs, PSMF, and deliver subject matter expert contribution to RMP, REMS and other related activities
Assume ownership of QMS documentation associated with post-approval PVG
Career expert in Safety & PVG, specifically in the post-approval environment
Bachelor’s degree or equivalent in a medical or science field, or equivalent education and experience
CRO industry experience preferred, EU QPPV experience valuable
Strong client relationship management skills
Strong understanding of PVG regulatory environment
Extensive leadership skills managing PVG teams in a range of therapeutic areas
Experience in winning and delivering a range of PVG projects
Leadership skills to provide direction to, and foster teamwork across multiple/complex projects
Ability to coach and develop others and to act as a catalyst for change
Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint) and email
Fluent in written and spoken English with strong verbal and written communication skills

Director, Safety & Security Resume Examples & Samples

Hire, develop and manage the performance of staff; assure staff is complaint with UI policies and procedures. Develop and implement policies and practices of a culture that supports staff engagement in the workplace. Develop/approve department budget and create systems for effective implementation and monitoring of human resource and financial systems
Oversee the analysis of complex data and preparation of reports on safety and security activities including trends and recommended remediation and prevention strategies
Prepare departmental reports for internal assessment, investigations, and other matters as needed
Oversee development and approve departmental budget
Review management / supervisor level applicants for Safety and Security Department positions and select best candidates
Assist in developing capital budgets for fire safety and security
Oversee the development of comprehensive safety and security hospital-wide training and chair the Safety Education Workgroup of the EOC Subcommittee
Review training programs to ensure they meet regulatory compliance requirements
Oversee S&S Department specific staff training requirements
Serve as institutional resource related to safety and serve on committees/groups in this capacity for the UIHC and UI
Provide functional and administrative supervision over staff providing safety, fire safety and security management functions
Recommend preventive actions to address potential risks that may occur in the work place
7-10 years of experience in workplace safety / security in a healthcare setting in a supervisory / leadership capacity
Experience with regulatory interaction and interpretation of OSHA, JC, CMS, NFPA and security standards
Demonstrated ability to work with a diverse group of staff at all levels of an organization
1-3 years of experience in public speaking and instructing/training development and delivery
1-3 years of experience with process improvement
A safety /security professional certification
Experienced in JC and OSHA surveys
Law enforcement experience as a commissioned officer

Associate Director, Safety Statistics Resume Examples & Samples

Responsible for resource management within SSG for assigned projects
As a leader in SSG, identify and implement best practice processes and safety analytic and graphic methods in collaboration with SSG colleagues across AbbVie therapeutic areas
Primary author of the Product Safety Statistical Analysis Plan and Integrated Summary of Safety Statistical Analysis Plan. Assure alignment across the PSSAP, the PSP, individual study SAPs, and the ISS SAP, and timely distribution of quality ISS, PSUR/PBRER, DSUR, IB, and RMP outputs
Represent SSG in strategic initiatives that address processes relating to interpreting, monitoring, assessing, and reporting safety data
MS/PhD in Statistics, Biostatistics or related field. Minimum 6 years of experience (PhD) or 12 years (MS) is required

Medical Director, Safety & Benefit Resume Examples & Samples

Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development)
Optimizes patient safety of Vertex products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of Safety activities through the product life cycle
Responsible for the safety assessment activities of assigned products under the supervision of a GPS Disease-area Safety Head
Autonomously monitors the benefit risk profile of assigned products/portfolio in an ongoing fashion and in accordance GPS processes and procedures
Lead the safety and risk management processes including chairing assigned Disease-area Safety and Product Safety Teams
Lead the development of safety-related responses to Safety queries from health authorities
Perform ongoing review of emerging safety data from various sources including single case reports, published literature, aggregate reports, and other sources
Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues
Conduct medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as needed
Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans
Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports
Effectively contribute to preparation and review of periodic reports (DSUR, PSUR, PADER) contributing medical strategy and expertise to content, authoring applicable analysis and content
Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter
Participate in departmental development activities including SOP and Work Instructions development
Provide a contributory role in Partner/Affiliate agreements and interactions, as needed
Other activities, as needed or as requested by GPS management
MD degree or equivalent (e.g., DO or MB) required
At least 5 years relevant Safety/Pharmacovigilance experience
Appropriate experience with Regulatory Agency and key stakeholder interactions
Experience with key Global PV/Regulatory approval activities, including NDA/MAA, RMP and REMS
Broad knowledge of medicine, pharmacovigilance and relevant regulations
Effectively communicates in written and spoken English
Strong influencing skills with the ability to explain and defend positions regarding significant issues in the face of opposition
Strategic focus regarding activities, with proactive planning and prioritization skills
Effective leader and team member

Director, Safety Statistics Resume Examples & Samples

Responsible for compliance with applicable corporate and divisional policies and procedures
Responsible for project and resource management within SSG for projects in Therapeutic Area(s) of responsibility
As a leader in SSG, ensure the identification and implementation of best practice processes and safety analytic and graphic methods in collaboration with SSG colleagues across AbbVie therapeutic and functional areas
Responsible oversight of timely development of Product Safety Statistical Analysis Plans (including Benefit Risk planning), Integrated Summary of Safety Statistical Analysis Plans, and his/her team’s deliverables; Ensure alignment of the PSSAP with the PSP, CSR and ISS SAPs, and timely and quality delivery of ISS, DSUR, PSUR/PBRER, IB, and RMP deliverables
Work with our partners in PPS and in Pipeline Statistics, Statistical Programming, and Data Sciences to strategically plan and ensure delivery of PSSAP and ISS SAP outputs according to agreed-upon timelines
Provide specifications on how the data should be integrated across studies in accordance with the PSSAP provided to statistical programming and ensure appropriate analyses and interpretation for PBRER/DSUR/IB/RMP/Regulatory Requests, signal evaluations and Safety Summary for NDA/BLA/Other Regulatory Activities
Understand and support the use of safety graphics for ongoing safety review and appropriate inclusion in safety documents as part of regulatory submissions
Represents SSG in strategic initiatives that address processes relating to interpreting, monitoring, assessing, and reporting Safety Data
Represent SSG/DSS on initiatives driven by external professional organizations such as ASA, PhUSE, DIA, etc
MS/PhD in Statistics, Biostatistics or related field. Minimum 10+ years of experience in pharmaceutical development and applied statistics/statistical consulting
·Experience with assessment of product safety is highly desired
Advanced knowledge of statistical methodology and global regulatory requirements; expertise in drug discovery or development
Must have demonstrated exemplary experience in managing and completing multiple projects or equivalent experience
3+ years of experience in leading a diverse group of statistical scientists, and oversight of safety-oriented projects
Demonstrated highly effective written and verbal communication skills and demonstrated ability to navigate, negotiate and influence benefit-risk and safety monitoring/integration
Proven ability to understand and implement relevant benefit-risk and/or safety monitoring methods and visualizations

Associate Director, Safety Device Vigilance Resume Examples & Samples

Ensures Company safety data collection and coding systems are consistent with current industry practices and meet all pertinent domestic and international regulatory requirements
Works actively in proposal development, prepares and participates in bid defenses as needed, and manages customer relationships. Serves as primary interface with vendors and other departments in the area of drug safety and coding
Provides expertise in the planning, execution, and maintenance of major projects. Provides project cost and budget reviews for proper budget maintenance
Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, Good Clinical Practices (GCPs), ICH guidelines, and the drug development process

Director, Safety Programs Resume Examples & Samples

15 years of progressive EHS experience in pharmaceutical, biochemical, chemical, petrochemical or process related industry with direct responsibility for safety program implementation and execution
Proven people and budget management experience
Detailed working knowledge of safety compliance, high risk work programs, process safety, fire safety and industrial safety/loss prevention
Direct experience in managing high risk work programs, safety engineering, fire safety and emergency response programs at the site, regional or global level
Proficiency in the use of all Microsoft based desktop software programs
Proven knowledge in development and management of General Safety, Process Safety and High Risk Work Programs in a process-related industry
Working knowledge of safety codes and standards (OSHA, ANSI, ISO, NFPA, IBC, UBC, UFC) and industry consensus standards (FM Global and XLGaps Guidelines)
Working knowledge Emergency Response
Proficient in written and oral communication, project management, people development
Proficient in development of technical tools and training programs for a global organization at the senior/line management and operational levels
Certification or registration as a Professional Engineer, Certified Safety Professional or Certified Fire Protection Specialist

Director, Safety CMS Resume Examples & Samples

Work closely with the Vice President CMS, CMS Directors, and Corporate Safety Directors to cultivate The National Grid Safety Culture. Including, providing health and safety leadership and direction to CMS Directors, Managers and Supervisors
Promote the philosophy of a safe working team across all activities relating to the pre-planning, scheduling and dispatching of unplanned (short cycle) gas and electric work, in order to achieve business objectives and continuously improve performance
Challenge existing norms related to safety processes and practices within the CMS organization and continuously seek ways to do things better in order to drive create a greater safety culture for the business
Work as the internal incident manager, ensuring that safety emergencies and injuries are properly managed and recorded
Conduct safety audits. Audits will include a brief summary report noting any deviations from the National grid Standards, as well as corrective actions that may be necessary to promote the health and safety of workers and the public. Organizes and conduct safety training as necessary
Create, manage and review site specific health and safety plans. Appraise and implement new safety regulations as they relate to National Grid operations
Oversee, manage and ensure health and safety plan orientations for all new CMS employees
Work closely with SHE in order to identify and respond appropriately to any potential hazards, incidents or circumstances that impact the safety, well being and working environment of National Grid employees
Assist in developing, coordinating, and implementing overall regional and yard level specific safety programs and projects
Typically role requires a minimum of 7 years experience
Understands theory behind policies and processes and demonstrates the ability to challenge existing processes and ways of working e.g. taking action to avoid future crisis or create opportunities to improve existing practices
4-year degree in safety, industrial hygiene or related field is preferred
Certified Safety Professional (CSP) or Certified Industrial Hygienist (CIH) designation is preferred
Detailed knowledge and understanding of safety issues affecting the utility industry. Demonstrates the ability to anticipate obstacles and think ahead about next steps
Professional qualification and experience within a specific field of expertise. Demonstrates the ability to apply and modify complex theories and learned concepts appropriately
Experience of understanding the work of a technical/professional functional area/business unit and demonstrates taking specific actions to enable the team to function safely and effectively
Demonstrates strong interpersonal skills including human resource management/negotiations/communications. Lets people affected by a decision know what’s happening and is able to clearly articulate reasons for a decision
Demonstrates the ability network internally and externally and to develop successful, long-lasting business relationships / partnerships with others and seeks to understand and challenge business scenarios to the benefit of all parties

Senior Corporate Director Safety Resume Examples & Samples

Achieve a sustainable 25% reduction in incurred claim costs. Year one should achieve 10%
Assess, recalibrate, reorganize and manage all Albertsons corporate safety activities and projects
Manage the integration and collaboration of all operational safety and risk management activities into Albertsons retail, distribution, manufacturing and transportation segments of the company
Has the authority to formulate, affect, interpret or implement management policies or operating practices. Implementation will be dependent upon gaining the buy-in and support of these programs from the Division Presidents
Provides consultation or expert advice to management
Is involved in planning long term and short-term business objectives
Investigates and resolves matters of significance on behalf of management
10 + years’ enterprise-wide operational risk management expertise
10+ years’ experience working in the retail industry with exposure to retail, distribution, manufacturing, and transportation
Strong knowledge of OSHA, DOT, and EPA regulations
Strong project design and project management/execution skills
Strong ability to communicate programs effectively within all levels of management and throughout the organization

Medical Director, Safety & Pharmacovigilance Resume Examples & Samples

Lead product safety surveillance, and signaling activities for assigned product(s) in collaboration with DSPV staff
Ensure development and implementation of other department goals, policies and strategies in collaboration with the DSPV management team, consistent with regulatory requirements and industry best practices
If applicable, manage Medical Director(s) and/or Associate Medical Director(s), overseeing their activities for assigned compounds / products
Other job duties that may be assigned according to business needs
Minimum of 3-years of experience in drug safety
Prior experience in patient care, clinical development and/or knowledge of clinical pharmacology desirable
Demonstrated strategic and critical thinking skills. Demonstrated leadership as well as the ability to perform effectively in a matrixed and dynamic environment, ability to lead and collaborate within complex organization, across functions and geographies; to work in an entrepreneurial culture
Excellent communication (oral and written) as well as organizational skills
Knowledge of pre- and post-marketing US and EU regulations

Director, Safety Resume Examples & Samples

Provide leadership and direction to assigned Safety Managers
Prevention of accidents and work related injuries
Trending of at-risk behaviors in assigned terminals
Trending of at-risk behaviors in assigned regions
Targeted actions and communications specific to identified risks
Driver Performance Improvement Plan: using Driver Scorecard (proactively, using triggering events) and observations
Identify driver concern trends
Facilitate improvement plans and process
Gauge and document results and track for sustained improvement
Oversight of regulatory compliance of assigned drivers and terminals
Hours of Service compliance
Credential Management
DVIR Process compliance
DVER Process and compliance
Develop and maintain the Driver Training (Onboarding) program, including oversight of the Trainer Selection process
Execute regularly scheduled Train the Trainer sessions on a regional basis
Build and maintain a “safety culture” that demands a continuous commitment to safety
Conduct Accident/ Injury investigation and reviews
Provide training and development to Operational Personnel and Drivers within assigned terminals
Provide safety messaging and collaboration with Regional Operations Directors within assigned region
Assess, evaluate, and lead the development and assignments of the Safety Coaches within assigned workforces
Lead and/or facilitate regular safety meetings within assigned driver force
Primary responsibility for the overall performance and scores within the CSA data and system
Oversee for compliance and proper administration of Drug and Alcohol testing within assigned workforce
Field and respond to accident reporting after hours as assigned
Cargo and Terminal Security
Four year degree in business related field preferred
Emotional control in stressful situations
Tolerance for working outside in various weather conditions
Certified Director of Safety preferred or at least one year experience inspecting commercial vehicles

Director Safety Physicians Resume Examples & Samples

Leads all Safety Physician operations at department and regional level
Manages and mentors Safety Physicians
Participates in leadership activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Reviews and approves time records, expense reports, requests for leave, and overtime (where appropriate)
Participates in proposals and bid defenses
Contributes to the maintenance of high quality standards and consistency as related to medical safety assessments
Contributes/leads meetings specific to medical safety assessment, such as Drug Safety Committee (DSC) meetings
Reviews all appropriate safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the product development life-cycle to support the analysis of similar events (AOSE) in clinical trials and to address labeling concerns, ad hoc and periodic safety reports and updates for medicinal product in the post-marketing setting
Conducts medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.) and provides an analysis of similar event (AOSE), as appropriate
Ensures medical accuracy of case narratives, coding, and medical sense of all cases and ensures appropriate queries are raised to expedite case closure
Authors/reviews the relevant safety sections of aggregate reports, including Periodic Benefit-Risk Evaluation Report (PBRER), as well as the benefit risk assessment of all aggregate safety reports such as Periodic Drug Safety Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), DSUR/IND Annual reports and line listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for regulatory submission; ensures the overall quality of the documents
Provides product-specific and general safety training to internal employees and external contractors / vendors as needed
Participates in investigators’ meetings to provide training on regulatory requirements for adverse events reporting as required
Prepares and may present product-specific safety issues at meetings, both internal and external
Reviews and finalizes new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety
Participates in drafting responses to queries from regulatory authorities or health care professionals on safety issues, legal queries, and requests involving safety issues, as appropriate
Maintains familiarity with MedDRA, WHODRL and safety databases such as ARGUS
Ensure ongoing safety monitoring of investigational and marketed products to include detection of signal and assessment of risk, assessment of the risk-benefit balance of products and analysis of the overall safety of products
Provides Medical contribution to risk management activities including Risk Management Plans (RMP) and Risk Evaluation and Minimization Strategy (REMS)

Director, Safety Resume Examples & Samples

Effectively communicate HSE strategy and objectives with Senior Leadership
Develop and implement training programs to transfer HSE knowledge and core competencies to management and associates
Support execution of Sysco’s Emergency Preparedness Plan procedures and policies
Maintains associate relations through regular department meetings; maintains on-going interaction and open communication with associates, monitors associate morale, and responds to and implements ideas to improve associate engagement and enablement
7 years hands-on environmental and safety experience in a warehousing/distribution, manufacturing, or transportation operation
Bachelor’s Degree strongly required
The ability to drive a strong safety philosophy and implement constructive behavior changes in transportation safety
Demonstrate excellent verbal communication, written communication, and presentation skills
Successfully demonstrate all Leadership Framework competencies
While performing the duties of this job, the employee is regularly required to sit, stand, walk and use hands and fingers to operate a computer keyboard, mouse, and telephone to talk and hear
The employee is frequently required to sit and reach with hands and arms
Must be able to do limited travel to Sysco facilities or operating companies

Senior Director, Safety Statistics Resume Examples & Samples

He/she is also accountable for ensuring that established standards and procedures are followed at all sites that supports global harmonization
The Head is also accountable for all deliverables from his/her group such as regulatory submissions and product safety
Senior leadership role that ensures utilization of expert statistical knowledge and best practices, to facilitate effective and informed decision making on pharmaceutical development projects
Responsible for providing high-level statistical representation for R&D with regulatory authorities, professional bodies and the academic community
Responsible for providing high-level statistical leadership and support for Global Medical Affairs (GMA) or Pharmacovigilance and Patient Safety (PPS) activities (e.g., Product Safety Statistical Analysis Plan (PSSAP), benefit and risk, publications, Exploratory Data Analysis, IIS review)
Balances capability and capacity of technical statistical expertise across all sites to optimize resource utilization
Accountable for successful and timely completion of clinical statistics project milestones and tasks
Responsible for the statistical content and validity of statistical argument within product license applications and for ensuring appropriate statistical review and assessment of potential in-licensing opportunities

Director Safety Resume Examples & Samples

Plans, develops, administers and coordinates all functions and services of health and safety for a collection of manufacturing locations (division)
Directs and controls the safety and health function for organization to reduce safety rates, financial losses, and eliminate occupational injuries and illnesses
Collaborates with peers in the organization to provide global support to ensure compliance with all applicable health and safety, environmental, and workers compensation regulations while focusing on the improvement of key performance indicators
Ensures field location compliance with federal, state and local law enforcement regulatory agency
Acts as a liaison between Senior Management, Plant Management and Employee on matters relating to safety and health
Plans and sets health and safety objectives and goals to be utilized by corporate and field locations
Oversees the reporting mechanisms for injuries, workers’ compensation, serious incidents, environmental releases ensuring compatibility with company objectives. Analysis expenditure, financial and operation reports to determine requirements for increasing safety and communicate recommendation to Senior Management
Assists as appropriate, in the recruitment process to include interviewing candidates, and providing input in the hire decision-making process for facility EHS Managers
Minimum of B.S. in Occupational Safety and Health or related field required, MS Preferred
Professional certification health and safety desirable
10 years of progressive health and safety experience, including at least five (5) years of corporate level experience of a company with multiple locations
Advance knowledge and understanding of existing OSHA, laws required
Must have the ability to work in a fast pace environment and work with multiple locations
Strong communication and organizational skills are required
Must be willing to travel extensively (50%+ may be expected)
Position can be based in Omaha, NE or Chicago, IL

Senior Director Safety Resume Examples & Samples

Conducts a thorough analysis of current functional strengths and weaknesses. Communicates the findings to senior leadership with a plan to drive action, and leverages continuous improvement tools to rapidly drive tangible improvements
Demonstrates influential leadership at all levels of the organization and takes the ownership and initiative to fill identified leadership gaps through collaboration and engagement
Drives to world-class levels of TIR, DART, LTIR and workers compensation cost by leveraging metrics-based performance management to identify opportunities and drive material improvement
Culturally institute Behavioral Based Safety program through solid partnership with manufacturing and functional leaders to continuously improve the behaviors, awareness and accountability systems to meet business safety objectives
Establish and maintain a clear vision and expectations regarding safety for our employees, contractors and any visitors in our work locations
Lead corporate EHS auditing function. Set clear and measurable expectations for safety performance. Establish, communicate and review commitments on a regular basis to ensure milestones are achieved. Demonstrate resilience and commitment to overcome obstacles to deliver on commitments
Coordinate and Manage Safety Manager duties at all facilities. Design and manage the safety organization creating accountability and development opportunities. Establish accountability process for ensuring alignment with operations leadership in talent management, expectation setting and performance management of safety talent
Ensure safety policies and procedures are compliant with local, state and federal OSHA rules and regulations and make necessary recommendations. Actively manage OSHA engagements at facilities through the on-site EHS Manager and in person where appropriate
Implement/Manage an EHS management system that embodies the elements in OSHA’s Voluntary Protection Program (VPP), OHSAS 18001, and ISO 14001)
Develop, facilitate, review and coordinate safety training for OSHA compliance and other safety related items, such as accident investigation and auditing with the facility safety manager
Develop and maintain a corporate balanced safety scorecard and diagnostic measurement system
Review accident/injury trends at plants and coordinates the programs that will reduce the trends
Provide assurance that personnel in all sites and at all levels have the necessary understanding of safety and sustainability policies, processes, regulations, etc. to fulfill their responsibilities and meet regulatory requirements
Ensure training for the First Responder Program is compliant and provide necessary direction
Review department safety audits and inspections for effectiveness
Review all existing and develop new safety awareness and incentive programs at each location. Collaborate with and connect Safety and Operations Leaders together to ensure corporate resources are advancing safety results
Working closely with Sr. Director, Workers Compensation, develop and implement programs to reduce Workers Compensation claims and costs, and ensure proper management and timely closure of all claims
Review all root cause analysis of safety incidents with facilities & leadership to assure the countermeasures are robust
Lead the corporate Safety team to ensure the strategic development of effective safety programs to eliminate injuries; effectively delegates while staying closely connected to execution of programs
Direct the planning, development and execution of supply chain environmental programs with a particular emphasis on energy, water, solid waste and waste-water in our manufacturing environment
Develop and maintain a corporate balanced sustainability scorecard, including development of new metrics and data collection systems to drive the sustainability agenda
Collaborate with internal business leads, including senior leadership, and external stakeholder groups to achieve key sustainability goals; develop strong relationships and partnerships to drive execution
Maintain understanding of leading trends and changes in corporate social responsibility, brand purpose and overall sustainability landscape, including regulatory issues
Serve as a contact and information source for sustainability initiative within the Supply Chain
Work closely with internal and external resources to develop creative and integrated sustainability programs
Establish and ensure adherence to budgets, schedules, work plans and performance requirements
Management of multiple manufacturing facilities, both union and non-union, required
Demonstrated ability to put pro-active behavior safety & sustainability programs in place
Minimum 15 years of applicable supply chain experience including manufacturing
Minimum of 5 years of experience in the field of EHS
Experience with OSHA and other standards, NFPA, EPA, etc
Excellent oral and written communications skills with the ability to interact with a wide range of perspectives from Board of Directors to shop floor employees
Currently 2 direct reports plus 12-15 dotted line reports

Assistant Director, Safety Statistics Resume Examples & Samples

Assist line management with resource management within SSG for assigned projects
As part of SSG, identify and implement best practice processes and safety analytic and graphic methods in collaboration with SSG colleagues across AbbVie therapeutic areas
For assigned projects, primary author of the Product Safety Statistical Analysis Plan (PSSAP) and Integrated Summary of Safety Statistical Analysis Plan. Ensure alignment across the PSSAP, the PSP, individual study SAPs, and the ISS SAP, and timely distribution of quality ISS, PSUR/PBRER, DSUR, IB, and RMP outputs
For assigned projects, provide specifications on how the data should be integrated across studies in accordance with the PSSAP provided to statistical programming and ensure appropriate analyses and interpretation for PBRER/DSUR/IB/RMP/Regulatory Requests, signal evaluations and Safety Summary for NDA/BLA/Other Regulatory Activities
MS/PhD in Statistics, Biostatistics or related field. Minimum 6 years of experience (PhD) or 10 years (MS) is required
Broad knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development
Prior experience should include interactions with regulatory authorities and oversight of safety-oriented projects
Demonstrated highly effective written and verbal communication skills and demonstrated ability to navigate, negotiate and influence benefit-risk and safety monitoring/integration data challenges
Awareness of key challenges in the rapidly evolving drug safety and benefit-risk environment

Corporate Director, Safety Resume Examples & Samples

Developing and providing technical and administrative direction on all safety policies and programs which bear critical importance to overall corporate objectives, operations and profitability of the various business units
Partnering with operations to create a work environment which reflects a commitment to protection of the safety of employees and provide safety training to operations
Partnering with operations and procurement to expand and enhance EQT’s contractor safety program to establish a safety culture for EQT’s supply chain vendors that support production and midstream operations and contractor fleet vehicles that support EQT’s operations
Reviewing internal safety policies and practices to ensure they are current and appropriate; conducting hazard and risk assessments and develop new or, where necessary, making recommendations to senior management to amend safety policies and procedures
Directing and enforcing compliance with all OSHA and DOT safety regulations pertaining to company operations, including changes to regulations
Providing regular written reports, as well as other production-related results and updates to the senior management team as required
Conducting (or coordinating) on-site safety training, reviews and audits of operations for all locations
Developing effective contractor safety processes
8+ years of experience managing and leading operational safety, preferably in the oil and gas, energy, mining industry or other related industry with distributed facilities
Experienced managing and leading fleet safety
Experience in managing contractor safety programs
Six Sigma or similar quality process experience is helpful

Business Finance Director, Safety Assessment Resume Examples & Samples

Serve as a member of the Global Safety Assessment finance leadership team
Education: Bachelor’s degree (B.A./B.S.) or equivalent required. MBA preferred
Experience: 10 or more years’ related experience in accounting/finance function, with three years of experience in financial analysis. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
Certification/Licensure: Recognized professional accounting designation (e.g., CPA, CA, CMA) required
Other:Previous supervisory experience preferred. Excellent communication skills required

Director, Safety & Security Resume Examples & Samples

Oversee the coordination and implementation of site security, operations, and activities to ensure protection of executives, managers, employees, guests, and physical and information assets
Develop and execute an integrated safety, security and protection strategy in collaboration with the Executive Team, Legal, and Systems Security, designed to provide a high level of safety and security over physical facilities, assets and business data while preserving and enhancing facility and system usability
Select, develop, train, guide and evaluate Safety and Security staff to ensure the efficient operation of the department
Provide consultation and leadership to all areas of the company for business continuity, incident management and disaster recovery planning
Ensure all aspects of the company's security policies and practices are developed, implemented, maintained and updated annually
Oversee the continuous monitoring and protection of facilities, personnel and technology. Evaluate and report suspected security breaches and take corrective actions
Consult on the design and implementation of a risk assessment program to define, identify, and classify critical assets, assess threats and vulnerabilities and implement mitigation strategies
Coordinate the development of an emergency response program that encompasses safety awareness, communication, training, injury prevention and documentation
Identify, collaborate with and manage a variety of safety and security vendors
Build and maintain relationships with public safety, both federal and local, as well as international security and intelligence agencies
Develop and implement security strategies, personal protection plans and information for employees traveling domestically and abroad. Manage all executive protection and travel safety programs
Plan, staff and oversee multiple internal and external events for safety and security considerations
Advise the Facilities Operations Department regarding security implications and risk for new construction and building
Assist in the development and administration (including training) of fire prevention and emergency response programs including inspection/testing of fire suppression systems
Oversee the administration of environmental, health and safety compliance and training programs
Coordinate, collaborate and liaise with Disney Global Security and other Disney Business Unit partners, both domestically and internationally
Advanced degree or equivalent in an area of study relevant to this position and at least ten to fifteen years experience in a private sector, corporate security or related public sector organization
Extensive knowledge of the security field, including corporate policies and practices related to physical security; executive and personnel protection; investigations; loss and incident reporting/analysis; risk and threat assessment/analysis; health and safety, major incident management planning and response; guard force operations and management; and integration of security into business operations
Strong leadership skills and ability to develop and lead staff
Demonstrated ability to develop strong relationships and work collaboratively with all levels of individuals inside and outside the organization
Strong analytical, investigative and problem-‐solving experience and abilities
Must be able to prove a high degree of personal integrity and emotional maturity
Strong desire and ability to research, innovate, and implement safety and security systems, technology and programs to stay relevant in the industry
Must be able to represent the organization with a high degree of professionalism
Strong communication skills including the ability to effectively communicate with all levels within the organization
Ability to prepare and deliver clear, succinct, and audience-‐appropriate written and oral reports for presentation to both technical and non-‐technical audiences
Must have an established network within the industry and government
Available 24x7x365 for any safety or security response to incidents

Director Safety Systems & Analysis Resume Examples & Samples

Develops and executes safety policies and programs, implementing throughout area of responsibility
Serves as a senior staff manager/advisor to Corporate VP and SVP. Serves as an advisor to AVPs, Corporate departments and fellow Managers & Directors concerning safety programs and teamwork
Develops and implements a Safety Operations Plan for Group(s), consistent with the accomplishment of long range established objectives which will enhance effectiveness and reduce risk expenditure
Supervises safety at all Areas & Business Units by researching regulations, determining needs, writing and disseminating information, and conducting reviews, including deep dive operational safety reviews
Supervises and directs regulatory training programs for employees including program development and scheduling of training sessions
Ensures drivers comply with Department of Transportation (DOT) and CSA regulations by providing them with guidance, information, and training; evaluates and auditing their compliance
Serves as principal safety officer for all locations through supervision of safety managers carrying responsibility and accountability for the safety of all employees
Maintains expert knowledge in safety rules and regulations. Reads and interprets OSHA, EPA, and DOT federal regulations, draws conclusions, and writes decisive guidelines and programs
Leads “Operating Rules Book” training, development and updating as required for Collections and Post Collection employees and Managers
Assists with Union or labor issues, including contract negotiations, labor events etc
Develops annual safety budget in a timely manner, forecasting financial and human resource needs for future time periods
Provides training for senior trainers
Represents VP of Safety as required
Indirect supervision and support of 15-40 full-time employees working across the organization
Education: High School Diploma or GED (accredited)
Experience: Ten years of relevant work experience in Operations and/or Safety (in addition to education requirement)
Strong operational and leadership background, leadership and training skills, accident investigation skills and root cause analysis, time management skills, risk management skills, and public speaking experience required

Assistant Director, Safety Management Resume Examples & Samples

Identify, initiate and implement process and workflow procedure improvements by monitoring and communicating workload projections and metrics for respective therapeutic areas and by participating in area budget process and proposals for assigned teams of healthcare professionals (approx. 5 to 40)
Function as a resource within Safety Management, Clinical Teams, and the larger organization with insight into industry trends and processes, and audit activities
May assist in development of department training programs, ongoing knowledge attainment, and development of staff, by effectively identifying department and staff needs and successfully presenting them to management
Assist management with strategic planning and development within Safety Management by facilitating incorporation of appropriate activities into therapeutic area teams activities and projects and demonstrating excellent interpersonal leadership, communication and development skills
Ensures application of clinical SOPs reflecting evolving global regulations and processes related to clinical trials are implemented within assigned teams; and clinical SOPs are being followed within assigned teams
Assists in the implementation of standardized clinical safety training and performance assessments by providing change leadership for technology and process improvements
Routinely interact with Divisional Vice President for therapeutic area(s), Product Safety Team, and AD/Directors in multiple cross-functional areas (Regulatory Affairs, Pharmacovigilance, Data Management, Clinical Field Operations, Clinical Program Management, Document Management)
Oversight of the timely capture of accurate quality, clinical adverse event information; and responsibility for resourcing model/plan for assigned therapeutic area(s) teams
Directly responsible for the design and execution of safety management activities including successful completion of CSR deliverables (e.g. narratives), TMF deliverables, etc. Operates independently, with recognition of risk
The potential actions of this position could impact the accuracy of decision-making regarding assigned products in clinical studies with respect to product approval and safety labeling (both marketed/un-marketed), patient safety and patient quality of life. Consequences of non-compliance could result in audits, warnings, penalties and sanctions that could impact both public safety and financial business goals
Bachelor's degree is required in nursing or scientific field. Advanced degree is desirable
8+ years of clinical development or directly related experience and 4 or more years of direct management experience
Must have demonstrated extensive knowledge in clinical safety reporting with cross discipline exposure and knowledge
Must have proven organizational, project management and leadership skills with the ability to lead the Safety Management organization within a global matrix environment
Must be able to understand the global environment from operations as well as regulatory/GCP perspective
Must have experience building effective working relationships across functions
Must have prior experience in resource planning
Must have demonstrated strong leadership competencies as a Clinical Safety Manager or equivalent with broad business orientation with leadership in standard business procedures (SOP, Global Regulations, OEC, Outsourcing, PV) and the application of those procedures to the business
Must be a subject matter expert, as a leader of initiatives and a key contributor to the advancement of Safety Management as an organization
Expert on Industry Best Practices in Clinical trial Safety that drive process improvement initiatives and implementations within assigned therapeutic areas

Group Executive Director Safety Resume Examples & Samples

Demonstrated experience leading safety and risk functions in large and complex organisations (e.g. with matrix reporting structure or in multi-agency environments)
Demonstrated experience leading organisational cultural change related to safety and risk
A relevant tertiary qualification
Broad understanding of general public sector management, the machinery of Government, political processes and Ministerial requirements

Director, Safety Pharmacovigilance Resume Examples & Samples

Oversees financial performance of assigned units; develops and manages top and bottom line revenue growth and expense budgets for drug safety and pharmacovigilance
Directs the drug safety and pharmacovigilance associates to achieve on-time quality customer deliverables, contractual project requirements, utilization goals, and profitable results
Effectively leads and encourages collaboration and work sharing between offices to create a unified global safety and pharmacovigilance team. Ensures best practices and processes are followed globally

Director, Safety Statistics Resume Examples & Samples

Leads by setting organizational strategies, goals, and priorities aligned with the business needs and strategies of Takeda
Supports achievement of major reporting deliverables and milestones in coordination with Pharmacovigilance and Medical Writing
MS or PhD in Statistics, Biostatistics, Computer Science or related analytical field
10+ years experience in the pharmaceutical industry and/or clinical research supporting clinical trials including multiple NDA/CTD submissions
5+ years experience supporting safety evaluation for development projects and/or marketed products
5+ years of line management experience
Proven track record in identifying and implementing organization-wide initiatives
In-depth knowledge of statistical analysis methodologies and reporting procedures for safety evaluations
Good knowledge of statistical programming languages (including SAS), software, techniques, and processes
Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft OfficeÒ products)
Active in statistical/statistical programming/pharmaceutical professional organizations
Advanced knowledge of FDA and ICH regulations and industry standards applicable to the safety evaluation of development projects/marketed products.Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces
Carrying, handling and reaching for objects
Ability to lift and carry over 25 pounds
Manual dexterity to operate office equipment i.e. computers, phones, etc