Medical Director, Drug Safety and Pharmacovigilance

Position: Medical Director, Medical Safety – ICSR (Patient Safety & Pharmacovigilance)

Responsibilities:
- Perform and oversee medical review of Individual Case Safety Reports (ICSRs), including complex oncology safety cases
- Assess adverse events (causality, seriousness, expectedness) and ensure narrative clinical accuracy
- Serve as primary medical point of contact for the pharmacovigilance vendor for day-to-day ICSR questions/escalations
- Provide medical input to vendor oversight (case quality review, triage accuracy, regulatory submission compliance)
- Develop medical review guidelines, training materials, and vendor-facing instructions
- Partner with Safety Operations on global case quality (monitor quality metrics; address non-compliance)
- Investigate quality events/deviations and CAPAs related to case processing and regulatory compliance; support CAPA development/implementation/tracking
- Participate in vendor governance as medical representative
- Support regulatory inspections/audits/health authority inquiries related to ICSR processing and review
- Maintain SOPs/work instructions for medical case review; act as safety point of contact for assigned molecule(s)
- Provide safety input for aggregate safety reports and key safety regulatory documents
- Partner with Safety Science, Regulatory Affairs, and Clinical teams on safety issues

Requirements:
- MD (or equivalent international medical degree) + 2+ years bedside clinical experience
- 5–8+ years oncology experience in drug safety/pharmacovigilance
- Strong hands-on ICSR medical review experience
- Experience working with external PV vendors/CROs
- Solid knowledge of global PV regulations (FDA, EMA, ICH)
- Strong medical judgment, attention to detail, matrix collaboration

Compensation/Benefits (as stated): Expected salary range $268,000–$331,000; medical/dental/vision, 401k, ESPP, wellness programs.