Pharmacovigilance Scientist Cover Letter

I submit this application to express my sincere interest in the pharmacovigilance scientist position.

In my previous role, I was responsible for leadership, project management and/or implementation support for various Clinical Development and Drug Safety/Pharmacovigilance systems projects and initiatives.

Please consider my experience and qualifications for this position:

• Demonstrates initiative in performing assigned tasks and responsibilities
• Able and willing to adjust behaviors and priorities based on changing environment
• Takes account, with guidance, of the internal and external environment when considering safety issues
• Ensures that adverse event and other safety information is efficiently evaluated and that safety reports are completed accurately and in a timely manner to meet global compliance and regulatory requirements
• Provides, with some support, clinical safety input on cross-functional teams
• Clinical/Medical writing and PV experience
• Comprehensive Analytic and Conceptual Skills
• Managerial experience directly managing people and or leadership experience leading teams, project, programs or directing the allocation of resources

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

Previously, I was responsible for expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and Good Pharmacovigilance Practice (GPvP).

Please consider my experience and qualifications for this position:

• Practical examples of end-to-end project management within Drug Safety/PV or relevant experience
• Knowledge and understanding of national & international PV and regulatory guidelines
• Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat computer skills
• RN or PharmD
• Experience as a contributor to periodic safety reports
• Clinical/Medical writing experience is preferred
• Working knowledge of applicable global, regional, and local regulatory requirements (eg, ICH guidelines) is preferred
• BS or BA in Life Science

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

Previously, I was responsible for pV input to the development of product Reference Safety Information (Core Company Safety Information, US Package Insert, Developmental Core Safety Information, Investigators Brochure, etc.), Summary of Clinical Safety, Integrated Summary of Safety, etc.

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:

• Experience in the preparation and authoring of individual and aggregate safety reports
• Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
• Global experience with or an equivalent combination of education and experience
• Clinical experience and knowledge of pharmacology, pharmacy, physiology or other relevant scientific discipline is preferred
• Authors Safety Assessment Reports and other safety documents (e.g., regulatory request
• Experience in signal detection, evaluation and management
• Experience in literature surveillance
• Experience in aggregate data analysis, interpretation and synthesis

Please consider me for the pharmacovigilance scientist opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for pV input to the development of product Reference Safety Information (Core Company Safety Information, Investigators Brochure, etc.), Summary of Clinical Safety, Integrated Summary of Safety, and other.

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

• Experience in authoring periodic aggregate safety reports and risk management plans
• Understanding of qualitative and quantitative safety data analysis methods
• Intermediate skills in the application of statistical and epidemiological methods to pharmacovigilance
• Clinical and/or medical research experience
• Extensive knowledge of ICH guidelines, safety systems
• Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), with external colleagues
• Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations
• Experience with development, authorship and review of aggregate reports (i.e., PSUR, DSUR, IND annual, NDA annual, ), Risk Management Plans, and Risk Evaluation and Mitigation Strategies

I submit this application to express my sincere interest in the pharmacovigilance scientist position.

Previously, I was responsible for safety content for new drug applications and other regulatory filings including review of the safety and benefit risk sections, review and preparation of relevant safety sections to ensure consistency across documentsand support response preparation.

Please consider my qualifications and experience:

• Intermediate understanding of epidemiology, preferred
• Advanced understanding of epidemiology, preferred
• MAA/BLA Submissions
• Periodic Reports
• Participate in ongoing safety data review and analysis for products in designated therapeutic areas
• Assists Global Safety Physicians in developing a strategy for safety-related regulatory activities
• Authors high quality aggregate safety reports to meet regulatory and internal deadlines
• Performs routine signal detection & discusses the results with safety physician for assigned products and ensures adequate documentation and tracking of the analysis results