Executive Medical Director, Global Pharmacovigilance & Risk

Exelixis; Alameda (CA); On-site; USD 250,000 - 350,000; Full time

Job summary

Exelixis is seeking an Executive Medical Director, PVRM to lead the global product safety strategy for complex oncology programs and post-marketing pharmacovigilance activities. You will mentor the safety team, drive proactive safety surveillance, and partner with cross-functional groups to plan and manage risk management and safety deliverables across development and lifecycle.

The role involves presenting safety data to Health Authorities and risk committees, developing core safety documents,

Qualifications

• MD degree and 10+ years of post-residency experience, or equivalent.
• Experience in pharmacovigilance in a pharma/biotech company.
• Leadership and management experience preferred.
• Pharmacovigilance experience in Oncology is a plus.

Responsibilities

• Lead safety strategy for complex oncology programs.
• Create data analysis strategies across clinical studies.
• Perform safety data interpretation on analyses.
• Set strategy for safety deliverables (signals, reports, risk management).
• Lead cross-functional Benefit Risk Team and escalate to BR Executive Committee.
• Develop core safety documents detailing product safety profile.
• Lead proactive safety data reviews and anticipate concerns.
• Oversee safety data evaluations in global aggregate reports.
• Present safety data to Health Authorities and boards.
• Develop risk management strategies and monitoring plans.
• Co-lead benefit-risk assessment with other functions.

Skills

Leadership

Cross-functional collaboration

Communication skills

Pharmacovigilance knowledge

Strategic thinking

Education

MD degree

10+ years post-residency

Job description

Exelixis is seeking an Executive Medical Director, PVRM to lead the global product safety strategy for complex oncology programs and post-marketing pharmacovigilance activities. You will mentor the safety team, drive proactive safety surveillance, and partner with cross-functional groups to plan and manage risk management and safety deliverables across development and lifecycle.

The role involves presenting safety data to Health Authorities and risk committees, developing core safety documents,