Lead medical review of individual case safety reports for oncology programs, with a focus on adverse event assessment, causality, seriousness, expectedness, and narrative quality. The role also supports safety input for key regulatory documents and works closely with pharmacovigilance, safety operations, regulatory, and clinical teams to keep global case processing inspection-ready.
Key Responsibilities
- Conduct medical review of ICSRs, including complex and medically significant oncology safety cases.
- Assess adverse events for causality, seriousness, expectedness, and overall clinical accuracy.
- Serve as the primary medical contact for the pharmacovigilance vendor on day-to-day case processing questions and escalations.
- Provide medical oversight of vendor case quality, triage accuracy, and regulatory submission compliance.
- Support development of medical review guidelines, training materials, and vendor-facing instructions.
- Monitor quality metrics, investigate deviations and non-compliance events, and support CAPA development and tracking.
- Participate in vendor governance meetings and support audits, inspections, and health authority inquiries.
- Contribute to SOPs, work instructions, and safety input for aggregate reports and other regulatory documents.
Required
- MD or equivalent international medical degree.
- At least 2 years of bedside clinical experience.
- 5 to 8+ years of oncology experience in drug safety or pharmacovigilance.
- Strong hands-on experience with ICSR medical review.
- Experience working with external pharmacovigilance vendors or CROs.
- Knowledge of global pharmacovigilance regulations, including FDA, EMA, and ICH.
Preferred
- Experience working in a matrixed environment.
- Experience providing safety input for clinical development and regulatory documents.
Benefits & Perks
- Competitive total rewards package.
- Eligibility for merit-based salary increases.
- Eligibility for discretionary short-term incentive participation.
- Eligibility for discretionary stock option awards, subject to board approval.
- Medical, dental, and vision coverage, with 100% company-paid employee coverage and 90% company-paid dependent coverage.
- 401(k), ESPP, and wellness programs.
- Onsite schedule of four days per week.