Risk Management Lead Resume Samples

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O Bogisich

Otis

Bogisich

348 Brown Points

Houston

+1 (555) 865 2072

348 Brown Points

Houston

Phone

p +1 (555) 865 2072

Experience Experience

Los Angeles, CA

Risk Management Lead

Los Angeles, CA

Hilll, Kuhlman and Blanda

Los Angeles, CA

Risk Management Lead

Manages direct reports & extended staff; delegates work, coaches, executes performance reviews
Provide primary point of contact and manage relationships with service providers
Assist in the management of Risk Management project timelines
Provide cybersecurity and risk management expertise for various initiatives and programs
Provide advice and liases with the Global Safety Leads that improve the consistency and accuracy of Benefit Risk assessment
Manage portfolio of products/projects related to risk management
Foster, manage, and build relationship with risk management vendors

Phoenix, AZ

IT Risk Management Lead

Phoenix, AZ

O'Kon-Marvin

Phoenix, AZ

IT Risk Management Lead

Develop, maintain and monitor security policy framework and internal controls best practices, manage the company’s security controls assessments and audit related tasks against security controls, and provide ongoing monitoring of status
Provide leadership in the selection, design, and configuration of controls, policies, and processes to ensure information security risk management
Possess and maintain broad technical and business knowledge of all aspects of information security and risk management
Formulate and define scope and objectives pertaining to the information security and risk management
Provide current best practice and third-party solution alternatives as part of the functional design document
Ensure service metrics relating to operational and third-party risk are maintained and collaborate with business and brands to assess the risk of potential initiatives
Provide design input on new services and solutions (e.g. solution architecture, app security, support model)

present

Los Angeles, CA

Pharmacovigilance & Risk Management Lead

Los Angeles, CA

Kris and Sons

present

Los Angeles, CA

Pharmacovigilance & Risk Management Lead

present

Quality control post-marketing safety reports, including case narratives
Collaborate with PVRM Risk Management in the development and implementation of local risk management planning strategies
Assist with CRO selection, budget reviews and work orders for outsourced local projects
Represent PVRM as lead contact, and collaborate with PVRM Licensing & Safety Agreement colleagues, to advise local stakeholders on the inclusion of Pharmacovigilance language in local contracts with third parties
Under the direction of the Quality Standards and Training group, take responsibility for the development of local quality management and the preparation of local SOPs/job aids (JBAs), ensuring integration with Global PVRM procedures
Assist with audit preparation
Represent PVRM at the local level through membership of the Country R&D Council (CRDC) ensuring interaction and communication across country R&D functions, contributing to compliance and inspection readiness and working with local Medical Directors to ensure two-way communication with Commercial colleagues with aligned objectives

Education Education

Bachelor’s Degree in Computer Science

Towson University

Bachelor’s Degree in Computer Science

Skills Skills

Ability to establish and maintain professional communication both internally and externally with all stakeholders
Ability to work with interdisciplinary, highly matrixed team
Ability to develop strategic plans and translate them to actionable roadmaps
Strong customer orientation and able to manage customer expectations
Strong business acumen and ability to negotiate to find win-win resolution to conflicts arising
Strong domain knowledge in global complex infrastructures 15+ years of project delivery and client relationship management in a technology environment
Good working knowledge of MS Word, Excel, PowerPoint and Outlook
An ability to clearly communicate to both business and IT audiences
Ability to work independently, take initiative and complete tasks to deadlines
Ability to respond appropriately to sensitive information and complaints

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15 Risk Management Lead resume templates

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Risk Management Lead Resume Examples & Samples

Under the oversight of the Sr. Director, Risk Management Strategy, coordinate and contribute to the development of risk management strategies for Shire marketed products
Implement specific risk management tools/programs for Shire marketed products
Analyze and interpret epidemiology and risk management data and disseminate results to a variety of internal and external audiences
Prepare risk management updates and progress reports for submission to Regulatory Agencies
Manage relationships with and progress of deliverables from internal and external stakeholders
Actively contribute to project and multifunctional teams including scheduling meetings, preparing agendas, preparing discussion materials, and taking minutes
Actively participate in Safety Review team meetings as required
Collaborate with the Shire Pharmacoepidemiology function in support of projects and activities undertaken for PVRM
Be the primary point of contact for service providers
Maintain up to date knowledge of Health Authority Guidance in regards to Pharmacovigilance and Risk Management globally
Maintain awareness of vendor capabilities in the area of pharmacovigilance and Risk Management
Manage confidentiality agreements, consultancy agreements, purchase orders, master service agreements, etc with vendors and consultants
Foster, manage, and build relationship with risk management vendors
Bachelor’s or Master’s degree in a science or healthcare related discipline
Experience in a medical field (RN, pharmacy) is preferred
Formal training or equivalent experience in epidemiology, public health, and/or risk management
Experience in Drug Safety or Pharmacovigilance preferred
Generally has 5+ years of experience in developing and implementing Risk Management Programs for pharmaceutical products
Ability to improvise and demonstrate creativity in solving problems and achieving objectives
Working knowledge of administrative healthcare databases and associated coding systems (ICD, CPT, NDC)
Proficiency with electronic search engines of the medical literature (MEDLINE, EMBASE, etc.)
Knowledge of global regulations and guidance on risk management
Knowledge of Shire involved therapeutic areas, disease management, treatments, etc
Requires strong attention to detail in composing and proof-reading materials, establishing priorities, scheduling and meeting deadlines
Excellent written, oral communication and presentation skills
Ability to work independently, take initiative and complete tasks to deadlines
Working knowledge of MedDRA terminology and practices is a must
Ability to respond appropriately to sensitive information and complaints
Good working knowledge of MS Word, Excel, PowerPoint and Outlook

Pharmacovigilance & Risk Management Lead Resume Examples & Samples

Fulfil the role of ‘Nominated Contact for Pharmacovigilance’ (NCPPV) according to local regulatory guidance and Shire policy. Serve as the lead contact for other nominated persons within regional/country responsibility ensuring effective communication of safety information and representation on the NCPPV Forum
Maintain knowledge of local pharmacovigilance regulations with particular reference to any deviations from standard ICH / EU definitions and requirements and communicate accordingly
Serve as primary contact point for all local pharmacovigilance matters, dealing with queries made via telephone, e-mail or face-to-face concerning general pharmacovigilance issues
Receive, acknowledge and assess post-marketing and investigational safety reports for entry into the drug safety database and request additional information where appropriate
Quality control post-marketing safety reports, including case narratives
Assist Operations colleagues with submission of expedited reports to Health Authorities as required. Ensure compliance with internal procedures, regulatory requirements and contractual requirements of pharmacovigilance agreements with business partners
Liaise with Quality Assurance colleagues as appropriate for local quality complaints
Under the direction of the Quality Standards and Training group, take responsibility for the development of local quality management and the preparation of local SOPs/job aids (JBAs), ensuring integration with Global PVRM procedures
Assist PVRM scientists / managers and physicians by collating relevant local information in support of their roles (i.e. data for aggregate report preparation, signal detection)
Liaise with PVRM physicians and scientists / managers to ensure that pharmacovigilance processes are adequately addressed and reflected in protocols/supporting documentation for local initiatives where safety data may be directly or indirectly collected. Collaborate with Clinical Development and Medical Affairs as appropriate
Represent PVRM as lead contact, and collaborate with PVRM Licensing & Safety Agreement colleagues, to advise local stakeholders on the inclusion of Pharmacovigilance language in local contracts with third parties
Collaborate with PVRM Risk Management in the development and implementation of local risk management planning strategies
Track product lists and requirements for periodic reporting for local products
Assist with audit preparation
Represent PVRM at the local level through membership of the Country R&D Council (CRDC) ensuring interaction and communication across country R&D functions, contributing to compliance and inspection readiness and working with local Medical Directors to ensure two-way communication with Commercial colleagues with aligned objectives
Represent PVRM as lead contact for pharmacovigilance on local project teams
Collaborate with PVRM physicians in making recommendations for local labelling changes, and in developing required regulatory documentation
Pharmacy qualification or other healthcare related degree (fulfilling requirements for a ‘nominated contact person for pharmacovigilance’ where applicable) is required
Generally has at least 5 years of drug safety experience in a pharmaceutical company with demonstrable writing skills
Post-graduate qualification is desirable
Fluent in Spanish. Use of English to a conversational level (but not at translation level). Knowledge of Portuguese will be an advantage
Strong clinical and post-marketing event assessment/review/documentation skills
Must be able to demonstrate strong knowledge of global clinical safety and pharmacovigilance regulations and ICH guidelines
Excellent communication skills and cultural awareness
Experience preparing, writing, authoring and submitting periodic safety reports
Experience of working with quality management processes and compliance monitoring
Working knowledge of MedDRA terminology and practices
Experience with safety databases (data entry, report generation and ad-hoc querying)
Requires strong attention to detail in composing and proofing-reading materials, establishing priorities, scheduling and meeting deadlines
Must be able to effectively present complex information to SPD management, CROs and the medical community

Pharmacovigilance & Risk Management Lead Resume Examples & Samples

Fulfil the role of the ‘Nominated Contact for Pharmacovigilance’ (NCPPV) according to local regulatory guidance (“Stufenplanbeauftragter” according to § 63a AMG (German Drug Law) for the following pharmaceutical companies: Shire Orphan Therapies GmbH, Shire Human Genetics Therapies AB, Shire Pharmaceuticals Ireland Limited, Shire Pharmaceutical Contracts Ltd) and Shire policy. Serve as the lead contact for other nominated persons within regional/country responsibilities ensuring effective communication of safety information and representation on the NCPPV Forum
Manage the local quality complaints process liaising with Quality Assurance colleagues as appropriate
Represent PVRM at the local level through membership of the Country R&D Council (CRDC) and Regional R&D Council ensuring interaction and communication across country R&D functions, contributing to compliance and inspection readiness and working with local Medical Directors to ensure two-way communication with Commercial colleagues with aligned objectives
Assist with CRO selection, budget reviews and work orders for outsourced local projects
Provide data to support local product registration, reimbursement and license maintenance activities
Supply information to PVRM physicians to allow preparation of regulatory responses to specific safety concerns with local marketed or investigational products
Communicate all potential issues to Senior Managers and the EU Qualified Person for Pharmacovigilance as appropriate
Pharmacy qualification or other comparable healthcare related degree (fulfilling requirements for a ‘Local Contact / Responsible Person’ where applicable) is required
Good level of drug safety experience in a pharmaceutical company with demonstrable writing skills

Shared Services Operational Risk Management Lead Resume Examples & Samples

Reporting into the Head of ShS ORM, the individual will be responsible for
Providing leadership within the Asia Pacific Region for Operational Risk Management across Shared Services
Developing strong relationships with the other ORM teams and to ensure effective partnerships across Shared Services
Independently oversee, advise, review and challenge Shared Services in various risk management activities, from both a regional perspective and as part of the global ORM Shared Services management team
Assist with, review, challenge, and provide quality assurance of the Risk & Control Self Assessments (RCSA) in accordance with the RCSA policy
Review and challenge internal incidents reported to determine root cause(s), assess existing control design and operation, identify issues and monitor remedial actions that mitigate the risk of occurrence of future losses, in accordance with the Incident Collation policy established by the firm
Provide leadership around ensuring the identification (and participation) in major Operational Risk remediation projects (and cross-divisional projects as required) to address issues in the risk and control environment
Attend regular partnership meetings with Shared Services stakeholders to help facilitate the identification, assessment, escalation and mitigation of Operational Risks and to continuously evaluate and improve the control issues

Risk Management Lead Resume Examples & Samples

Provide cybersecurity and risk management expertise for various initiatives and programs
Interface with cyber security subject matter experts to gather inputs and develop policy analysis and reports
Provide planning, documentation, logistics, and execution support for public/private cyber security and risk management meetings and events
Engage in public/private collaboration efforts to enhance cyber security capabilities within the energy sector
Research, review and report various best practices, industry cyber security developments, standards, and guidelines
Coordinate with internal and external partners to assess stakeholder needs and increase program congruency
Track, report, and address requests pertaining to public/private collaboration efforts and cyber security programs
Master’s degree in cybersecurity, computer science, or business
Intensive discipline and 10 years of experience in managing large, complex security, risk management, exercises, and critical infrastructure protection projects
Must have experience working with cybersecurity laws, programs, policies, and stakeholders in the US electricity, oil, and natural gas industries
Must also have knowledge of cybersecurity practices for both Information Technology (IT) and Operations Technology (OT)
Understanding of energy sector cyber security and critical infrastructure protection best practices
Experience with Department of Energy, energy sector organizations, or energy sector associations
At least one of the following certifications: CISA, CISSP, CISM, Security +, PMP
Experience in assisting public-private collaboration efforts
Experience developing or analyzing public policy
Experience in designing and implementation of standards and best practices
Program or project management
Ability to lead a team of technical experts and mentor junior staff members
Conduct relationships in a mature and professional manner to C-level executives
Aptitude for working autonomously and prioritizing
Ability to multitask and prioritize according to changing circumstances
Robust interpersonal skills
Strong analytical, problem solving and decision making capabilities
Team player with the ability to work in a fast paced environment workload to achieve goals
Excellent verbal, interpersonal and written communication skills

Risk Management Lead Resume Examples & Samples

Ensures the associated processes meet objectives
Influences peers and management
Ability to operate and influence at IT leadership level
Must be able to work within a matrix organization – balancing the needs of the service ownership and overall IT ownership initiatives and goals. Includes matrix leadership and influence of domain, project and operations responsibilities
Must make decisions and negotiate with customers and overcome obstacles
Manage multiple and diverse program colleagues and stakeholder expectations to deliver objectives
Identify, manage and resolve complex issues, preventing escalations, where possible
Manage, negotiate and resolve project risks effectively
Demonstrate, by example, in-depth knowledge of the EY competency principles and practices, including coaching, teaching and mentoring
Leader and team player – sets example for sub-leads and resources to follow
Significant personal responsibility and autonomy
Plans own work, to meet given objectives and processes
Build positive relationships with internal professionals by demonstrating integrity and genuineness
Manages direct reports & extended staff; delegates work, coaches, executes performance reviews
Directs staff in the development/implementation of the process to meet business requirements
Required to understand and integrate cultural differences/motives in order to manage cross-cultural/cross border teams
Required to manage sensitive personnel matters
Escalation point for staff issues
At least 10 years experience in an IT role, ideally within a professional services environment
Persistence to ensure deliverables are completed successfully
An ability to clearly communicate to both business and IT audiences
Proven track record of driving operational excellence and improving processes
Demonstrated experience of complex technology environments, including recent process re-engineering experience
An overall understanding of the business objectives of service lines and Core Business Services departments
Ability to lead projects and motivate others
Excellent collaboration skills in a matrix organization
Excellent management, problem solving, communication, interpersonal, and organizational skills
Strong domain knowledge in global complex infrastructures 15+ years of project delivery and client relationship management in a technology environment
Strong business acumen and ability to negotiate to find win-win resolution to conflicts arising
Ability to develop strategic plans and translate them to actionable roadmaps
Outstanding interpersonal, communication, and organizational skills
Overtime may be required as per country overtime policy
A valid passport required; willingness and ability to travel internationally

Risk Management Lead Resume Examples & Samples

Summarize safety data from investigational and marketed use
Authoring RMP’s, REMS to meet regulatory and internal deadlines
Critically review documents produced for scientific content and alignment with company position, clarity, accuracy, and consistency and f facilitate document review by other contributors
Ensure all safety regulatory documents are processed and submitted according to regulatory requirements
Manage portfolio of products/projects related to risk management
Write and prepare risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies
Assist in the management of Risk Management project timelines
Represent Risk Management on cross functional teams
Interface with other Shire functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed
Contribute to on-going process enhancement for safety surveillance such as developing standard procedures and templates
Participate in other teams and committees as assigned

Cybersecurity Risk Management Lead Resume Examples & Samples

Partner with IT Risk and business cybersecurity officers on cybersecurity global controls
Assess adequacy of firmwide cybersecurity controls to mitigate cybersecurity risks, identify issues, lead or assist in development of action plans
8+ years of business experience, ideally including experience in the Financial Services and Technology Risk or related fields
Ability to develop and maintain strong partnerships with key stakeholders, and to work across LOBs and regions, balancing the needs of multiple organizations
Ability to both learn from colleagues and think outside the box

Obsolescence & Risk Management Lead Resume Examples & Samples

Supports Obsolescence Management Working Group (OMWG) 　
Accurate and timely documentation of maintenance and licensing agreements 　
Create risk mitigation recommendations in line with Diminishing Manufacturing Sources and Material Shortages (DMSMS) to reduce program risks 　
Assesses cost, schedule and technical risk of obsolescence mitigation recommendations, including impacts to existing Infrastructure Architecture 　
Present Obsolescence Management risks at technical, logistics, and programmatic reviews 　
6 years of related work experience required
Experience using industry tools including GIDEP and market/vendor research to gather data and identify trends relevant to the mitigation of obsolescence issues 　
Experience developing and leading risk management and mitigation recommendations 　
Background in system supportability analysis, sustaining/logistics engineering, and system life cycle support 　
Ability to obtain a Secret Security Clearance (DOD Secret)-US Citizenship required　
Bachelor's degree in engineering/science 　
Minimum of 6 years’ experience of progressively responsible professional engineering/scientific experience, including ground and/or space systems and a background in systems engineering, enterprise architecture, technical and project leadership in an engineering organization or program office

Risk Management Lead Resume Examples & Samples

8+ years of experience in engineering and risk management
Experience in executing USAF, AFSPC, or DoD risk analysis, tracking, and handling policies, processes, and documentation
Experience in identifying and analyzing risks and developing follow-on handling strategies and plans
Experience with systems engineering pertaining to development, operations, and acquisition programs, including requirements development, design reviews, test and evaluation, operational acceptance, training, modeling and simulation, and scheduling
Experience with Microsoft Office applications, including Word, PowerPoint, Excel, and Project
Experience with working in and supporting collaborative teams supporting a technically complex task
Ability to proficiently facilitate meetings and conduct briefings
BA or BS degree in Engineering
5+ years of experience in program management
Experience with USAF space systems processes and procedures regarding acquisition, development, operations, maintenance, and sustainment
Experience with VBA programming
Possession of excellent organizational and technical writing skills
MA or MS degree in Management or Engineering

EME Risk Management Lead Resume Examples & Samples

Develop people in order to ensure succession plan and a high performance team
Develop and implement risk mitigation tools to support the business : Customer Financing , Insurance, Hedging and Barter Operations
Guarantee compliance of all transactions and processes
Lead initiatives and projects to improve processes and operational excellence
Ensure Credit Policy, Credit Models review to guarantee the sustainable business growth
Visit to customers , establish the relationship with key areas in order to assure the TCB processes and strategies are updated and aligned
Control credit risk exposure by region and supply headquarters with managerial reports to explain variation between actual and forecast
Develop the Credit, Treasury and Barter Strategy plan to support the LRP business growth
Support Pension Plan Management
Manage entity capital structure
Deliver Cash flow targets
Management of local F/X hedging strategy, in accordance with Headquarter (St. Louis)
Manage institutional relations with banks and suppliers to support business needs
Control SG&A (spend) for Credit, Treasury and Commodities Teams
Establish and maintain focus on Macroeconomic scenario to evaluate and anticipate business impact
Guarantee the optimization of bank relationship, services, products and credit support
Bachelor in Business Administration, Economics, Accounting or Engineering,
10-15 years of prior experience in Finance or Areas with Finance Background
Strong Credit and Treasury background with emphasis in Risk Management
Prior experience leading large teams
Credit & Customer Finance Instruments; Credit Risk Management; Treasury Risk Management (Cash flow, currency exposure, BS and P&L exposure, Financial (bank) Instruments
Fluent business English is essential; with other languages is an advantage

Pharmacovigilance & Risk Management Lead Resume Examples & Samples

Serve as point of contact for and collaborates with colleagues from Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other related departments
Performs Medical Review of adverse event reports including but not limited to all serious, events of interest, and expedited individual case safety reports ensuring that appropriate medical interpretation, consistency and quality are applied to adverse event case assessment
Generates or assists with input to Analysis of Similar Events
Participates in review of scientific literature: identify case reports that meet criteria for entry into the safety database; identify relevant safety articles / references involving the active ingredients of marketed products and products in development
Performs review of coding (eg. reaction, suspect/concomitant product, indication, laboratory data, medical history)
Provides support for investigator brochures, protocols, informed consents, final study reports, as appropriate
Provides medical guidance for aggregate reports
Contributes to safety issue evaluation and management for the life cycle of product
Contributes to signal detection, monitoring, evaluation, interpretation and appropriate management of safety information
Provides input to key internal safety documents, including Risk Management documents (REMS, RMPs), development and updates/maintenance of expectedness guides
Prepares and may present individual case safety report issues, aggregate data analyses and interpretation, and proposed risk mitigation strategies for discussion at internal meetings
Participate in ad-hoc projects or assignments that require medical input
5+ years’ pharmacovigilance experience in drug development pharma/biotech industry. Medical Degree required. Experience with FDA and working with regulatory groups preferred. Previous experience with risk mitigation strategies preferred. Experience specific to CNS / neurology /respiratory/oncology preferred but not required

Risk Management Lead Resume Examples & Samples

Performs forensic analysis of digital information and gathers and handles evidence
Identifies network computer intrusion evidence and perpetrators
Investigates computer fraud or other electronic crimes, crack files and system passwords, detects steganography and recovers deleted, fragmented and corrupted data from digital media of all types
Ensures chain of custody and control procedures, documents procedures and findings in a manner suitable for courtroom presentation and prepares comprehensive written notes and reports
May be required to testify in court as expert witnesses
Secret Clearance required

IT Risk Management Lead Resume Examples & Samples

5+ years of experience in information security & risk management
2+ years in a leadership role
CISSP (required)
Demonstrable experience managing IT projects (required)
EGRC platform experience (previous Archer experience preferred)
Knowledge of NIST and ISO 27001 (preferred)
CRISC (preferred)
Knowledge of pharmaceutical industry (preferred)

Risk Management Lead Resume Examples & Samples

Responsible for the implementation of benefit-risk management for Shire products. Development of REMS, DRMP’s & RMP’s, regulatory responses for risk management topics and other product position statements as assigned for submission to regulatory agencies
Actively participates in Benefit- Risk Committees and other safety committees as needed. Effectively manages the Benefit/Risk process
Prepares and assists in the management of Risk Management project timelines. Ensure all risk management documents are prepared according to regulatory requirements, facilitate review and sign-off. Ensure all regulatory commitments in RMP’s are followed & tracked
Represent Risk Management on cross functional teams and Interface with other Shire functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed
Communicates effectively on product risks to Risk Management Team Lead
Provide advice and liases with the Global Safety Leads that improve the consistency and accuracy of Benefit Risk assessment
Critically review & provide medical/safety input of PBRER, RMP, DSUR, Clinical Expert statement, Regulatory responses, IB, NDA Submissions, MAA Submission & ad hoc reports. Ensures that the safety risks with Shire projects/products are identified promptly
Represent GDS- Risk Management for internal and external Risk Management forums as safety and risk management experts, including regulatory agency meetings such as EMA, FDA as needed,
Participate in other activities, teams and committees as assigned
MD, PhD or Pharm D with specialty training in functional area at least 3 plus years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products
At least 2 year of experience writing and preparing risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies
Previous experience in bioscience preferred
Product defense before a national or international regulatory authority a plus
Ability to work with interdisciplinary, highly matrixed team
Knowledge and active use of Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat
Oral and written communication and interpersonal skills
Ability to manage multiple projects simultaneously while remaining responsive to strict deadlines
Ability to establish and maintain professional communication both internally and externally with all stakeholders

Risk Management Lead Resume Examples & Samples

Critically review & provide medical/safety input of PBRER, RMP, DSUR, Clinical Expert statement, Regulatory responses, IB, NDA Submissions, MAA Submission & ad hoc reports. Ensures that the safety risks with Shire projects/products are identified promptly Represent GDS- Risk Management for internal and external Risk Management forums as safety and risk management experts, including regulatory agency meetings such as EMA, FDA as needed, Contribute to on-going process enhancement for safety surveillance such as developing standard procedures and templates Participate in other activities, teams and committees as assigned
MD, PhD, Pharm D or healthcare related educational background with specialty training in functional area at least 3 plus years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products
Previous experience in bioscience preferred Product defense before a national or international regulatory authority a plus Ability to read and analyze scientific and medical literature Ability to work with interdisciplinary, highly matrixed team Knowledge and active use of Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat Analytical and problem solving skills Oral and written communication and interpersonal skills Planning and Organizing Ability to manage multiple projects simultaneously while remaining responsive to strict deadlines Ability to establish and maintain professional communication both internally and externally with all stakeholders

Cybersecurity IT Risk Management Lead Resume Examples & Samples

Partner in design of compensating controls where standards do not cover risks
Support Global Cyber Partnerships & Government Strategy efforts to identify risk of potential legislation
Partner with Independent Risk on Cybersecurity Key Risk Indicators
Collaborate with Firmwide Cybersecurity colleagues and other internal teams, including but not limited to Legal, Compliance, Oversight & Control and management teams
Bachelors degree in computer science, information systems or related field along with 8+ years of overall IT experience preferred
Strong organizational and time management skills; ability to manage multiple and conflicting priorities in a global organization, and to adapt in a fast-paced environment
Strong PC skills including thorough knowledge of Microsoft Office Suite

Risk Management Lead Resume Examples & Samples

Provide advice and liaises with the Global Safety Leads that improve the consistency and accuracy of Benefit Risk assessment
Represent GDS- Risk Management for internal and external Risk Management forums as safety and risk management experts, including regulatory agency meetings such as EMA, FDA as needed
MD, PhD or Pharm D with specialty training in functional area at least 5 plus years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products
At least 3 year of experience writing and preparing risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies

Risk Management Lead With Polygraph Resume Examples & Samples

Bachelor's degree in Accounting, Business, Finance or other Business-related field
4+ years of experience performing financial statement audits and/or auditability assessments
4+ years of experience in reviewing, analyzing, validating, and reconciling financial/accounting information
2+ years in a technical or functional lead role
Experience mentoring and coaching others
Proven leadership skills demonstrating strong judgment, problem-solving, and decision-making abilities
Experience managing senior-level client relationships
Experience presenting to clients or other decision makers to present and sell ideas to various audiences (technical and non-technical)
Pre-sales, proposal, and RFP experience
Experience establishing and monitoring enterprise internal controls and act as chief audit executive
Active TS/SCI Security clearance with Polygraph is required

Risk Management Lead Resume Examples & Samples

5+ years of experience with IT or Cybersecurity
DoD 8570.01 IAT Level II certification, including Security+
Experience with supporting DoD clients
Experience with eMASS

Risk Management Lead-ts Resume Examples & Samples

Bachelor's Degree in accounting, finance, business administration, or related field preferred
Master of Business Administration or Certified Public Accountant preferred
Ten or more years of business unit/account management experience
Experience working with generally accepted financial management principles
Six or more years of leadership experience preferred

CIB Market Risk Management Lead Resume Examples & Samples

Ensure compliance with local regulatory requirements around Market Risk
Accountable for all regulatory market reports that are submitted to Senior Management, Risk Committee and regulators
Point of contact for local regulators, external auditors for entity specific regulatory market risk issues
Meet with senior managers and effectively discuss market risk limits, exposures, methodologies and regulatory requirement
Provide advisory on potential impacts of risk taking positions and new business initiatives
Work with technology teams to create dynamic, accurate, and automated regulatory legal entity reporting for the Bank
Previous experience in the Latin America markets with thorough knowledge of Market Risk
Knowledge of local regulatory requirements
Previous experience with regulators and dealing with regulatory requirements is a plus
Trading Products knowledge
Strong analytical & quantitative skills with focus on risk management
Strong attention to detail and superior organizational skills
Clear oral and written communication in English
Strong time management skills – should be able to work well under pressure managing several time sensitive deadlines
Fluency Portuguese and English