Patient Safety Medical Director
Vertex Pharmaceuticals
August 07, 2026
Remote friendly (Boston, MA)
United States
Medical Affairs
General Summary:
Lead safety and benefit-risk activities for products in your Disease Area/Franchise (including pre-franchise products through commercialization). Ensure consistent, compliant safety assessment, analysis, and reporting across world markets. Lead pre-marketing risk assessment, FIH study safety planning, regulatory submission safety content (SCS, CLO, Labeling), and planning/execution of RMPs and/or REMS for and post-marketing. Partner with Clinical Teams, Medical Affairs, and Partners to proactively assess and address safety issues across the product life cycle.
Key Duties and Responsibilities:
- Provide leadership/oversight of Safety Team(s): pre-FIH activities, benefit-risk assessment, DST strategy.
- Coordinate/oversee safety signals detection.
- Develop/implement Risk Management procedures/plans with Clinical Leaders.
- Lead safety document development for submissions (SCS, CLO, Label, RMP or equivalent).
- Support pharmacoepidemiology study development/implementation/reporting.
- Review/assist D/PSURs, IND packages, and NDA/IND/MAA Annual Safety Reports.
- Provide safety input for labeling.
- Partner with Regulatory Affairs on responses to safety inquiries.
- Oversee medical review of AE reports (aggregate and individual).
- Evaluate safety information from toxicology, non-clinical, and product quality sources.
- Oversee medical content for key documents (Protocols, Analysis Plan, IB, ICF, IDMC Charter) and safety data analyses from trials.
- Serve as departmental SME (SOP development) and facilitate staff/direct report growth.
Qualifications/Skills:
- Broad knowledge of General Medicine; extensive GCP/ICH/global regulations.
- Strong matrix leadership/communication.
- Experience evaluating/interpreting data; synthesize into messaging.
- Comprehensive benefit-risk strategy/decision-making.
- Ability to multitask.
Education/Experience:
- M.D. required.
- Typically 7 years’ experience (some pharmacovigilance) and 5 years’ supervisory/management experience (or equivalent).
Compensation:
- $276,000–$414,000 base salary. Eligible for annual bonus and annual equity awards; some roles may be eligible for overtime.
Lead safety and benefit-risk activities for products in your Disease Area/Franchise (including pre-franchise products through commercialization). Ensure consistent, compliant safety assessment, analysis, and reporting across world markets. Lead pre-marketing risk assessment, FIH study safety planning, regulatory submission safety content (SCS, CLO, Labeling), and planning/execution of RMPs and/or REMS for and post-marketing. Partner with Clinical Teams, Medical Affairs, and Partners to proactively assess and address safety issues across the product life cycle.
Key Duties and Responsibilities:
- Provide leadership/oversight of Safety Team(s): pre-FIH activities, benefit-risk assessment, DST strategy.
- Coordinate/oversee safety signals detection.
- Develop/implement Risk Management procedures/plans with Clinical Leaders.
- Lead safety document development for submissions (SCS, CLO, Label, RMP or equivalent).
- Support pharmacoepidemiology study development/implementation/reporting.
- Review/assist D/PSURs, IND packages, and NDA/IND/MAA Annual Safety Reports.
- Provide safety input for labeling.
- Partner with Regulatory Affairs on responses to safety inquiries.
- Oversee medical review of AE reports (aggregate and individual).
- Evaluate safety information from toxicology, non-clinical, and product quality sources.
- Oversee medical content for key documents (Protocols, Analysis Plan, IB, ICF, IDMC Charter) and safety data analyses from trials.
- Serve as departmental SME (SOP development) and facilitate staff/direct report growth.
Qualifications/Skills:
- Broad knowledge of General Medicine; extensive GCP/ICH/global regulations.
- Strong matrix leadership/communication.
- Experience evaluating/interpreting data; synthesize into messaging.
- Comprehensive benefit-risk strategy/decision-making.
- Ability to multitask.
Education/Experience:
- M.D. required.
- Typically 7 years’ experience (some pharmacovigilance) and 5 years’ supervisory/management experience (or equivalent).
Compensation:
- $276,000–$414,000 base salary. Eligible for annual bonus and annual equity awards; some roles may be eligible for overtime.