Exec Medical Director, Pharmacovigilance Risk Management (PVRM)
Exelixis
August 07, 2026
Remote friendly (United States)
United States
Operations
Job Purpose
- Develop and execute global product safety strategy for complex clinical development programs and post-marketing pharmacovigilance activities. Lead and mentor teams to plan/manage safety surveillance, analyses, risk management, and safety document deliverables; collaborate cross-functionally to support corporate development strategy.
Responsibilities
- Lead and develop safety strategy for oncology products in clinical development or with marketing authorization.
- Create safety data analysis strategies across clinical studies; interpret results.
- Set strategy for safety deliverables (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filing documents, clinical development documents).
- Lead cross-functional Benefit Risk Team and escalate key safety updates to the Benefit Risk Executive Committee.
- Lead development of core safety documents; conduct proactive safety data reviews and anticipate safety concerns.
- Oversee safety evaluations/summaries for global periodic safety aggregate reports.
- Present safety data and provide safety expertise at key meetings (e.g., with Health Authorities, DSMBs, investigators).
- Develop risk management strategies and effectiveness monitoring plans; co-lead benefit-risk assessments.
- Supervise direct reports; partner with clinical development, biometrics, medical affairs, and regulatory affairs.
Qualifications
- M.D. and 10+ years post-residency (or equivalent education/experience).
- 3+ years clinical experience post-residency.
- 10+ years pharmacovigilance experience (or relevant pharma/biotech experience such as clinical research); oncology PV is a plus.
- Board Certification (US) preferred; prior project/team leadership preferred.
Skills/Knowledge
- Deep knowledge of US/EU pharmacovigilance regulations and application across the product lifecycle.
- Strong analytical, organizational, and communication skills; advanced problem-solving.
Benefits/Total Rewards
- 401(k), medical/dental/vision, life/disability insurance, flexible spending accounts, discretionary annual bonus/incentive, stock purchase, long-term incentives, vacation/holidays, sick days.
Application/Instructions
- If you need a recruiting accommodation, email ApplicantAccommodations@exelixis.com.
- Develop and execute global product safety strategy for complex clinical development programs and post-marketing pharmacovigilance activities. Lead and mentor teams to plan/manage safety surveillance, analyses, risk management, and safety document deliverables; collaborate cross-functionally to support corporate development strategy.
Responsibilities
- Lead and develop safety strategy for oncology products in clinical development or with marketing authorization.
- Create safety data analysis strategies across clinical studies; interpret results.
- Set strategy for safety deliverables (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filing documents, clinical development documents).
- Lead cross-functional Benefit Risk Team and escalate key safety updates to the Benefit Risk Executive Committee.
- Lead development of core safety documents; conduct proactive safety data reviews and anticipate safety concerns.
- Oversee safety evaluations/summaries for global periodic safety aggregate reports.
- Present safety data and provide safety expertise at key meetings (e.g., with Health Authorities, DSMBs, investigators).
- Develop risk management strategies and effectiveness monitoring plans; co-lead benefit-risk assessments.
- Supervise direct reports; partner with clinical development, biometrics, medical affairs, and regulatory affairs.
Qualifications
- M.D. and 10+ years post-residency (or equivalent education/experience).
- 3+ years clinical experience post-residency.
- 10+ years pharmacovigilance experience (or relevant pharma/biotech experience such as clinical research); oncology PV is a plus.
- Board Certification (US) preferred; prior project/team leadership preferred.
Skills/Knowledge
- Deep knowledge of US/EU pharmacovigilance regulations and application across the product lifecycle.
- Strong analytical, organizational, and communication skills; advanced problem-solving.
Benefits/Total Rewards
- 401(k), medical/dental/vision, life/disability insurance, flexible spending accounts, discretionary annual bonus/incentive, stock purchase, long-term incentives, vacation/holidays, sick days.
Application/Instructions
- If you need a recruiting accommodation, email ApplicantAccommodations@exelixis.com.