Safety Lead Cover Letter

I submit this application to express my sincere interest in the safety lead position.

In the previous role, I was responsible for relevant inputs for enhancements of current systems and processes; Provide safety input as it relates to post marketing signal detection activities to safety documents, as well as ad hoc Health Authority queries.

Please consider my experience and qualifications for this position:

• Detailed knowledge of Pharmacovigilance Agreements and contract management
• Practical experience with the interpretation and implementation of pharmacovigilance regulations
• Knowledge of pharmacovigilance systems and user aspects of validation
• Competence in business process analysis and process improvement
• Competence in development and maintenance of standard operating procedures
• PV audit and inspection experience desirable
• Strong interpersonal, networking and alliance management skills including expertise in negotiation and influencing others
• Unquestionable integrity / Honesty

I would like to submit my application for the safety lead opening. Please accept this letter and the attached resume.

Previously, I was responsible for drug safety systems application and operational support to the Pharmacovigilance and Epidemiology department.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Strong understanding and application of federal, provincial and local environmental and safety regulations and requirements, including those related to transportation
• An experienced manager
• Strong familiarity with safety consulting services delivery methodologies and tools
• TUV Engineer or Expert level certification (or equivalent)
• Strong people management skill-sets and experience
• Degrees of a medical nature (e.g Medical Doctor, Pharmacist) or life sciences
• Strong understanding of the relevant local and regional (EMEA) PV regulatory framework
• Oversees management and authoring of aggregate data reports

I would like to submit my application for the safety lead opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for continuous educational updating on relevant regulations, standards and best practice information to relevant departments and staff.

My experience is an excellent fit for the list of requirements in this job:

• Working knowledge of CENELEC standards EN50126/8/9
• Knowledge of State and National Rail Safety legislation and Safety Management Systems
• Deep knowledge of legislation and HP regulations across multiple states, provinces, or countries
• Demonstrated technical leadership, capacity of influencing, convincing
• Comfortable working with the ambiguity inherent in implementing new technologies, complex Functional Safety products
• Recognized as a technical leader in his/her previous experiences
• Course work in safety or environmental issues preferred
• Argus ,Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat

I am excited to be applying for the position of safety lead. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for timely EHS reports and statistics to management to include: KPI reports, leading and lagging indicators, relevant deviations from expected performance.

My experience is an excellent fit for the list of requirements in this job:

• Primary location will be DC8, New Albany, but could work within our other Campuses as needed
• Experience with U.S. Navy and International Submarine Combat Control Systems design
• Experience with IBM Rational DOORS or Telelogic DOORS
• Experience working with the Submarine Warfare Federated Tactical Systems (SWFTS) Community
• Experience with the AN/BYG-1 Combat Control System
• PSP (Physical Security Professional) certification strongly preferred
• Prior experience with aggregate report preparation or in Regulatory Affairs specific to aggregate report distribution is strongly preferred
• Experience with safety reporting and regulatory compliance, and knowledge of international safety reporting/regulations is preferred

I am excited to be applying for the position of safety lead. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for training to Pharmacovigilance department staff on the safety reporting process and procedures and relevant associated PPD systems, with training materials.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Displays a sound understanding of the scientific basis for therapies and drug-induced diseases
• Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle
• Able to act independently, seeking guidance as appropriate
• Recognizes other colleagues’ areas of expertise and utilizes them effectively to achieve team objectives
• Relevant knowledge of Pharmaceutical Company organizational structure, policies, and practices, as applicable to safety Risk Management
• Strong change and stakeholder management skills
• Working knowledge of other OSHA, EPA and DOT regulations preferred
• Previous experience leading implementation of EHS programs using a project management approach preferred