Patient Safety Associate Medical Director
Vertex Pharmaceuticals
August 12, 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). Optimize patient safety and maintain compliance with global pharmacovigilance regulations through timely safety activities across the product life cycle.
Key Duties And Responsibilities:
- Provide medical safety expertise, pharmacovigilance, and safety risk management for assigned products.
- Conduct safety assessment activities under the supervision of a GPS Disease-area Safety Head.
- Monitor the benefit-risk profile on an ongoing basis per GPS processes.
- 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 from single case reports, literature, aggregate reports, and other sources.
- Serve as medical safety lead on cross-functional study/program teams; provide safety guidance.
- Perform medical evaluation of safety-related information from toxicology/non-clinical studies and product quality complaints as needed.
- Participate in protocol development (safety information monitoring/collection) and statistical analysis plans.
- Analyze safety data from ongoing/completed clinical trials; contribute to Clinical Study Reports.
- Contribute to periodic reports (DSUR, PSUR, PADER), including medical strategy and content.
- Provide medical content for key study documents (e.g., IB, ICF, IDMC Charter).
- Assist with departmental SOP and work instruction development.
- Guide staff on adverse experience report collection, evaluation, and processing.
- Support partner/affiliate agreements and interactions as needed.
- Perform other activities as requested.
Knowledge And Skills:
- Broad knowledge of medicine, pharmacovigilance, and relevant regulations.
- Ability to deliver high-quality safety documents.
- Data management/system concepts; pharmacoepidemiology and statistics; interpret complex data.
- Communicate complex issues effectively.
- Strong influencing skills; explain/defend positions.
- Strategic planning and prioritization; ownership and delegation.
- Technical expertise in pharmacovigilance and clinical safety.
- Analytical/problem-solving skills with 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 experience in Safety/Pharmacovigilance or equivalent education and experience.
The Patient Safety Associate Medical Director will provide medical safety expertise, pharmacovigilance, and safety risk management for assigned products (marketed or in development). Optimize patient safety and maintain compliance with global pharmacovigilance regulations through timely safety activities across the product life cycle.
Key Duties And Responsibilities:
- Provide medical safety expertise, pharmacovigilance, and safety risk management for assigned products.
- Conduct safety assessment activities under the supervision of a GPS Disease-area Safety Head.
- Monitor the benefit-risk profile on an ongoing basis per GPS processes.
- 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 from single case reports, literature, aggregate reports, and other sources.
- Serve as medical safety lead on cross-functional study/program teams; provide safety guidance.
- Perform medical evaluation of safety-related information from toxicology/non-clinical studies and product quality complaints as needed.
- Participate in protocol development (safety information monitoring/collection) and statistical analysis plans.
- Analyze safety data from ongoing/completed clinical trials; contribute to Clinical Study Reports.
- Contribute to periodic reports (DSUR, PSUR, PADER), including medical strategy and content.
- Provide medical content for key study documents (e.g., IB, ICF, IDMC Charter).
- Assist with departmental SOP and work instruction development.
- Guide staff on adverse experience report collection, evaluation, and processing.
- Support partner/affiliate agreements and interactions as needed.
- Perform other activities as requested.
Knowledge And Skills:
- Broad knowledge of medicine, pharmacovigilance, and relevant regulations.
- Ability to deliver high-quality safety documents.
- Data management/system concepts; pharmacoepidemiology and statistics; interpret complex data.
- Communicate complex issues effectively.
- Strong influencing skills; explain/defend positions.
- Strategic planning and prioritization; ownership and delegation.
- Technical expertise in pharmacovigilance and clinical safety.
- Analytical/problem-solving skills with 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 experience in Safety/Pharmacovigilance or equivalent education and experience.