Director, Global Drug Safety & Pharmacovigilance Physician
Genmab
June 25, 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 throughout their lifecycle management. Individual contributor role (no direct people management). Reports to the Vice President, MD Team Lead.
Responsibilities:
- Lead major pre- and post-marketing safety activities (signal, benefit-risk evaluation, risk management) for own area
- Collaborate with drug safety and cross-functional teams on safety assessment (AEs and scientific literature; safety reports), ongoing surveillance, and related communications
- Oversee safety issues, implement risk mitigation activities, and propose systemic solutions
- Provide inputs to trial protocols/amendments/plans, clinical trial reports, eCRFs/CRFs, TMFs
- Prepare regulatory documentation (e.g., benefit/risk sections of aggregate reports; safety summaries)
- Manage internal/external forums (e.g., DMCs; Genmab Safety Committees)
- Provide safety guidance, oversight, and training to stakeholders (employees, CROs, investigators)
- Engage proactively with internal/external stakeholders (e.g., multidisciplinary groups, experts/partners, regulatory authorities)
- Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations
Requirements:
- MD required
- 12+ years’ experience in drug safety/pharmacovigilance (clinical development and post-marketing), preferably in oncology
- Experience with BLA and/or NDA submission; PV audits with participation in regulatory authority inspections; work with FDA/other authorities
- Knowledge of global PV regulatory environment (regulations, initiatives, standards, GVP); MedDRA and WHODrug; AE case processing, triage, and medical review
- Experience with safety databases (ARISg, ARGUS, or similar) and EDC systems (preferred)
- Experience mentoring/guiding team members
Benefits (US first-year eligibility): 401(k) 100% match on first 6%; medical/dental/vision; paid vacation/sick/holidays; 12 weeks discretionary paid parental leave; backup care/family support; commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Compensation (US): Salary band $235,840–$353,760 (additional incentives may apply).
Responsibilities:
- Lead major pre- and post-marketing safety activities (signal, benefit-risk evaluation, risk management) for own area
- Collaborate with drug safety and cross-functional teams on safety assessment (AEs and scientific literature; safety reports), ongoing surveillance, and related communications
- Oversee safety issues, implement risk mitigation activities, and propose systemic solutions
- Provide inputs to trial protocols/amendments/plans, clinical trial reports, eCRFs/CRFs, TMFs
- Prepare regulatory documentation (e.g., benefit/risk sections of aggregate reports; safety summaries)
- Manage internal/external forums (e.g., DMCs; Genmab Safety Committees)
- Provide safety guidance, oversight, and training to stakeholders (employees, CROs, investigators)
- Engage proactively with internal/external stakeholders (e.g., multidisciplinary groups, experts/partners, regulatory authorities)
- Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations
Requirements:
- MD required
- 12+ years’ experience in drug safety/pharmacovigilance (clinical development and post-marketing), preferably in oncology
- Experience with BLA and/or NDA submission; PV audits with participation in regulatory authority inspections; work with FDA/other authorities
- Knowledge of global PV regulatory environment (regulations, initiatives, standards, GVP); MedDRA and WHODrug; AE case processing, triage, and medical review
- Experience with safety databases (ARISg, ARGUS, or similar) and EDC systems (preferred)
- Experience mentoring/guiding team members
Benefits (US first-year eligibility): 401(k) 100% match on first 6%; medical/dental/vision; paid vacation/sick/holidays; 12 weeks discretionary paid parental leave; backup care/family support; commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Compensation (US): Salary band $235,840–$353,760 (additional incentives may apply).