Director, Global Drug Safety & Pharmacovigilance Physician
Genmab
August 08, 2026
Remote friendly (Princeton, NJ)
United States
Medical Affairs
The Drug Safety & Pharmacovigilance (GDS&PV) Physician (Director) is a safety expert medical role contributing to the global safety strategy and overall safety profile for assigned Genmab products across their lifecycle. Individual contributor role (no direct people management); reports to the Vice President, MD Team Lead.
Responsibilities:
- Lead major pre- and post-marketing safety activities for own area (signal, benefit-risk evaluation, risk management).
- Collaborate with drug safety and cross-functional teams for safety assessment (review of AEs and literature; safety reports), ongoing surveillance, and communications.
- Oversee safety issue handling, implement risk mitigation, and propose systemic solutions.
- Provide inputs to trial/clinical documents (protocols/amendments, clinical trial reports, eCRFs/CRFs, TMFs).
- Prepare regulatory documentation (e.g., benefit/risk sections; safety summaries such as submission modules 2.7.4, clinical overview).
- Manage internal/external safety forums (e.g., external DMCs; Genmab Safety Committees).
- Provide guidance, oversight, and training on safety to stakeholders (employees, CROs, investigators) and mentor junior colleagues.
Requirements:
- MD required.
- 12+ years drug safety/pharmacovigilance experience in clinical development and post-marketing (preferably oncology).
- BLA and/or NDA submission experience; PV audit process with participation in Regulatory Authority inspections; work with FDA and other regulators.
- Global PV regulatory environment (GVP), MedDRA and WHODrug; AE case processing/triage/medical review.
- Safety databases (ARISg, ARGUS, or similar) and eDC preferred.
Compensation (US based): $235,840.00–$353,760.00. Benefits (eligible within first year for regular full-time US employees) include 401(k) match, health/dental/vision, paid time off, and 12 weeks discretionary paid parental leave.
Responsibilities:
- Lead major pre- and post-marketing safety activities for own area (signal, benefit-risk evaluation, risk management).
- Collaborate with drug safety and cross-functional teams for safety assessment (review of AEs and literature; safety reports), ongoing surveillance, and communications.
- Oversee safety issue handling, implement risk mitigation, and propose systemic solutions.
- Provide inputs to trial/clinical documents (protocols/amendments, clinical trial reports, eCRFs/CRFs, TMFs).
- Prepare regulatory documentation (e.g., benefit/risk sections; safety summaries such as submission modules 2.7.4, clinical overview).
- Manage internal/external safety forums (e.g., external DMCs; Genmab Safety Committees).
- Provide guidance, oversight, and training on safety to stakeholders (employees, CROs, investigators) and mentor junior colleagues.
Requirements:
- MD required.
- 12+ years drug safety/pharmacovigilance experience in clinical development and post-marketing (preferably oncology).
- BLA and/or NDA submission experience; PV audit process with participation in Regulatory Authority inspections; work with FDA and other regulators.
- Global PV regulatory environment (GVP), MedDRA and WHODrug; AE case processing/triage/medical review.
- Safety databases (ARISg, ARGUS, or similar) and eDC preferred.
Compensation (US based): $235,840.00–$353,760.00. Benefits (eligible within first year for regular full-time US employees) include 401(k) match, health/dental/vision, paid time off, and 12 weeks discretionary paid parental leave.