Executive Medical Director, Pharmacovigilance Risk Management
New
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ExelixisPharmacovigilance, oncology
Source API remote eligibility restrictions: United StatesFull-TimeExecutive
SalaryUSD 399000 - 504000 / year
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Job Details
- Experience
- A minimum of 10 years of post-residency experience; at least 10 years of pharmacovigilance experience or other relevant experience.
- Required Skills
- Risk Management
Requirements
- Hold an M.D. degree and have a minimum of 10 years of post-residency experience, or an equivalent combination of education and experience.
- Have at least 3 years of clinical experience after residency.
- Have at least 10 years of pharmacovigilance or other relevant experience, such as clinical research, in a pharmaceutical or biotechnology company.
- Demonstrate knowledge of US and EU pharmacovigilance regulatory requirements and general regulatory expectations.
- Demonstrate knowledge of US and international pharmacovigilance regulations and their practical application throughout the product lifecycle.
- Board certification, if US-based, is preferred.
- Oncology pharmacovigilance experience is a plus.
- Prior project and team leadership or management experience is preferred.
Responsibilities
- Lead and develop safety strategy for complex clinical development programs and products with marketing authorization.
- Create safety data analysis strategies across clinical studies and interpret the resulting analyses.
- Set strategy for safety deliverables, including safety signals, aggregate reports, risk management planning, data pooling, and regulatory and clinical development documents.
- Lead the cross-functional Benefit Risk Team and escalate important safety updates to the Benefit Risk Executive Committee.
- Lead development of core safety documents that characterize the product's safety profile.
- Lead proactive safety data reviews and anticipate safety concerns.
- Oversee safety data evaluations and summaries in global periodic safety aggregate reports.
- Present safety data and provide product safety expertise at meetings with Health Authorities, Data Safety Monitoring Boards, and Investigators.
- Develop risk management strategies and monitoring plans to assess their effectiveness.
- Co-lead product benefit-risk assessment with other functions and mentor direct reports.
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