Patient Safety Associate Medical Director
Vertex Pharmaceuticals
September 02, 2026
Remote friendly (Boston, MA)
United States
Medical Affairs
General Summary:
The Patient Safety Associate Medical Director provides medical safety expertise, pharmacovigilance, and safety risk management for assigned products (marketed or in development), optimizing patient safety and ensuring compliance with global pharmacovigilance regulations through safety activities across the product life cycle.
Key Duties and Responsibilities:
- Provide medical safety, pharmacovigilance, and safety risk management for assigned products
- Perform safety assessment activities under a GPS Disease-area Safety Head
- Monitor benefit-risk profiles for assigned products/portfolio
- Lead safety and risk management processes; chair Disease-area Safety and Product Safety Teams
- Identify, prioritize, and analyze clinical safety signals per GPS procedures
- Review emerging safety data (ICSRs, literature, aggregate reports)
- Serve as medical safety lead on cross-functional study/program teams
- Conduct medical evaluation of relevant safety information (toxicology, non-clinical, product quality complaints)
- Contribute to protocol development (safety monitoring/collection) and statistical analysis plans
- Analyze safety data from clinical trials and contribute to Clinical Study Reports
- Contribute to periodic reports (DSUR, PSUR, PADER)
- Provide medical content for study documents (e.g., IB, ICF, IDMC Charter)
- Support SOP/work instruction development; guide adverse experience report collection/evaluation
- Support partner/affiliate agreements as needed; other GPS management needs
Knowledge and Skills:
- Broad knowledge of medicine, pharmacovigilance, and relevant regulations
- Strong data, pharmacoepidemiology/statistics understanding; interpret complex information
- Ability to communicate, influence, and strategically plan/prioritize
- Technical expertise in pharmacovigilance and clinical safety; strong analytical/problem-solving skills
- Regulatory Agency and key stakeholder interaction experience
- 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 Safety/Pharmacovigilance experience (or equivalent combination)
Compensation:
- Pay range: $200,000–$300,000
- Eligible for annual bonus and annual equity awards; some roles may be eligible for overtime pay
The Patient Safety Associate Medical Director provides medical safety expertise, pharmacovigilance, and safety risk management for assigned products (marketed or in development), optimizing patient safety and ensuring compliance with global pharmacovigilance regulations through safety activities across the product life cycle.
Key Duties and Responsibilities:
- Provide medical safety, pharmacovigilance, and safety risk management for assigned products
- Perform safety assessment activities under a GPS Disease-area Safety Head
- Monitor benefit-risk profiles for assigned products/portfolio
- Lead safety and risk management processes; chair Disease-area Safety and Product Safety Teams
- Identify, prioritize, and analyze clinical safety signals per GPS procedures
- Review emerging safety data (ICSRs, literature, aggregate reports)
- Serve as medical safety lead on cross-functional study/program teams
- Conduct medical evaluation of relevant safety information (toxicology, non-clinical, product quality complaints)
- Contribute to protocol development (safety monitoring/collection) and statistical analysis plans
- Analyze safety data from clinical trials and contribute to Clinical Study Reports
- Contribute to periodic reports (DSUR, PSUR, PADER)
- Provide medical content for study documents (e.g., IB, ICF, IDMC Charter)
- Support SOP/work instruction development; guide adverse experience report collection/evaluation
- Support partner/affiliate agreements as needed; other GPS management needs
Knowledge and Skills:
- Broad knowledge of medicine, pharmacovigilance, and relevant regulations
- Strong data, pharmacoepidemiology/statistics understanding; interpret complex information
- Ability to communicate, influence, and strategically plan/prioritize
- Technical expertise in pharmacovigilance and clinical safety; strong analytical/problem-solving skills
- Regulatory Agency and key stakeholder interaction experience
- 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 Safety/Pharmacovigilance experience (or equivalent combination)
Compensation:
- Pay range: $200,000–$300,000
- Eligible for annual bonus and annual equity awards; some roles may be eligible for overtime pay