Patient Safety Associate Medical Director
Vertex Pharmaceuticals
June 29, 2026
Remote friendly (Boston, MA)
United States
Medical Affairs
General Summary:
- The Patient Safety Associate Medical Director will provide medical safety expertise, pharmacovigilance, and safety risk management for assigned products (marketed or in development) to optimize patient safety and maintain compliance with global pharmacovigilance regulations through timely completion of safety activities across the product life cycle.
Key Duties And Responsibilities:
- Provide medical safety expertise, pharmacovigilance, and safety risk management for assigned products.
- Perform safety assessment activities under the supervision of a GPS Disease-area Safety Head.
- Monitor benefit-risk profiles for assigned products/portfolio.
- Lead safety and risk management processes; chair assigned Disease-area Safety and Product Safety Teams.
- Identify, prioritize, and analyze clinical safety signals per GPS procedures.
- Review emerging safety data (ICSRs, published literature, aggregate reports, etc.).
- Serve as medical safety lead on cross-functional study/program teams; provide safety guidance.
- Conduct medical evaluation of safety-related information from toxicology/non-clinical and product quality complaints as needed.
- Participate in protocol development (safety information collection/monitoring and statistical analysis plans).
- Contribute to analysis of safety data from clinical trials; support Clinical Study Reports.
- Prepare/review periodic reports (DSUR, PSUR, PADER) with medical strategy and analysis/content.
- Review medical content for study documents (IB, ICF, IDMC Charter).
- Assist with SOP/work instruction development.
- Guide staff on adverse experience report collection/evaluation/processing.
- Support partner/affiliate agreements and interactions as needed.
Knowledge And Skills:
- Broad knowledge of medicine, pharmacovigilance, and relevant regulations.
- Experience delivering high-quality safety documents.
- Knowledge of data management/systems, pharmacoepidemiology, and statistics.
- Strong communication, influencing, strategic planning, ownership, and delegation.
- Technical expertise in pharmacovigilance and clinical safety.
- Analytical/problem-solving skills with sound autonomy and judgment.
- Experience with Regulatory Agency and stakeholder interactions.
- Experience with ICSR case review and aggregate safety analysis/reports.
Education And Experience:
- MD, DO, or equivalent ex-US medical degree.
- Typically 3 years of relevant experience in Safety/Pharmacovigilance (or equivalent education/experience).
Flex Designation:
- Hybrid: work remotely up to two days per week, or On-Site: work five days per week on-site with ad hoc flexibility.
- The Patient Safety Associate Medical Director will provide medical safety expertise, pharmacovigilance, and safety risk management for assigned products (marketed or in development) to optimize patient safety and maintain compliance with global pharmacovigilance regulations through timely completion of safety activities across the product life cycle.
Key Duties And Responsibilities:
- Provide medical safety expertise, pharmacovigilance, and safety risk management for assigned products.
- Perform safety assessment activities under the supervision of a GPS Disease-area Safety Head.
- Monitor benefit-risk profiles for assigned products/portfolio.
- Lead safety and risk management processes; chair assigned Disease-area Safety and Product Safety Teams.
- Identify, prioritize, and analyze clinical safety signals per GPS procedures.
- Review emerging safety data (ICSRs, published literature, aggregate reports, etc.).
- Serve as medical safety lead on cross-functional study/program teams; provide safety guidance.
- Conduct medical evaluation of safety-related information from toxicology/non-clinical and product quality complaints as needed.
- Participate in protocol development (safety information collection/monitoring and statistical analysis plans).
- Contribute to analysis of safety data from clinical trials; support Clinical Study Reports.
- Prepare/review periodic reports (DSUR, PSUR, PADER) with medical strategy and analysis/content.
- Review medical content for study documents (IB, ICF, IDMC Charter).
- Assist with SOP/work instruction development.
- Guide staff on adverse experience report collection/evaluation/processing.
- Support partner/affiliate agreements and interactions as needed.
Knowledge And Skills:
- Broad knowledge of medicine, pharmacovigilance, and relevant regulations.
- Experience delivering high-quality safety documents.
- Knowledge of data management/systems, pharmacoepidemiology, and statistics.
- Strong communication, influencing, strategic planning, ownership, and delegation.
- Technical expertise in pharmacovigilance and clinical safety.
- Analytical/problem-solving skills with sound autonomy and judgment.
- Experience with Regulatory Agency and stakeholder interactions.
- Experience with ICSR case review and aggregate safety analysis/reports.
Education And Experience:
- MD, DO, or equivalent ex-US medical degree.
- Typically 3 years of relevant experience in Safety/Pharmacovigilance (or equivalent education/experience).
Flex Designation:
- Hybrid: work remotely up to two days per week, or On-Site: work five days per week on-site with ad hoc flexibility.