Director, Global Drug Safety & Pharmacovigilance Physician
Genmab
August 30, 2026
Remote friendly (Princeton, NJ)
United States
Medical Affairs
The Drug Safety & Pharmacovigilance (GDS&PV) Physician role is a safety expert medical role contributing to the global safety strategy and overall safety profile for assigned Genmab products throughout their lifecycle management. Director level individual contributor; reports to the Vice President, MD Team Lead.
Responsibilities:
- Lead major pre- and post-marketing safety activities: signal detection, benefit-risk evaluation, and risk management for own area.
- Collaborate with drug safety and cross-functional teams on safety assessment (AEs and scientific literature), ongoing surveillance, and communications.
- Oversee safety issues, implement risk mitigation, and propose systemic solutions.
- Provide inputs to trial documents (protocols/amendments/plans, clinical trial reports, eCRFs/CRFs, TMFs).
- Prepare regulatory-required safety documentation (benefit/risk sections, safety summaries such as submission module 2.7.4, clinical overview).
- Manage internal/external forums (e.g., Data Monitoring Committees, Genmab Safety Committees).
- Provide guidance, oversight, and training on safety to stakeholders (employees, CROs, investigators).
- Engage proactively with internal and external stakeholders (experts/partners; regulatory authorities for audits/inspections).
- Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations.
Requirements:
- MD required.
- 12+ years’ experience in drug safety/pharmacovigilance in clinical development and post-marketing (preferably oncology).
- Experience with BLA and/or NDA submissions; PV audit process with participation in Regulatory Authority inspections; work with FDA and other regulators.
- Global PV regulatory environment (regulations, initiatives, standards, GVP); MedDRA & WHODrug coding; AE case processing, triage, and medical review.
- Safety database experience (ARISg, ARGUS, or similar) and electronic data capture systems (preferred).
- Experience guiding/mentoring team members.
Benefits (US-based candidates): $235,840–$353,760 salary band; eligible for additional compensation (discretionary bonuses/long-term incentives). 401(k) match; health, dental, vision; paid time off; discretionary paid parental leave; backup care/family support and wellness tools; commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Responsibilities:
- Lead major pre- and post-marketing safety activities: signal detection, benefit-risk evaluation, and risk management for own area.
- Collaborate with drug safety and cross-functional teams on safety assessment (AEs and scientific literature), ongoing surveillance, and communications.
- Oversee safety issues, implement risk mitigation, and propose systemic solutions.
- Provide inputs to trial documents (protocols/amendments/plans, clinical trial reports, eCRFs/CRFs, TMFs).
- Prepare regulatory-required safety documentation (benefit/risk sections, safety summaries such as submission module 2.7.4, clinical overview).
- Manage internal/external forums (e.g., Data Monitoring Committees, Genmab Safety Committees).
- Provide guidance, oversight, and training on safety to stakeholders (employees, CROs, investigators).
- Engage proactively with internal and external stakeholders (experts/partners; regulatory authorities for audits/inspections).
- Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations.
Requirements:
- MD required.
- 12+ years’ experience in drug safety/pharmacovigilance in clinical development and post-marketing (preferably oncology).
- Experience with BLA and/or NDA submissions; PV audit process with participation in Regulatory Authority inspections; work with FDA and other regulators.
- Global PV regulatory environment (regulations, initiatives, standards, GVP); MedDRA & WHODrug coding; AE case processing, triage, and medical review.
- Safety database experience (ARISg, ARGUS, or similar) and electronic data capture systems (preferred).
- Experience guiding/mentoring team members.
Benefits (US-based candidates): $235,840–$353,760 salary band; eligible for additional compensation (discretionary bonuses/long-term incentives). 401(k) match; health, dental, vision; paid time off; discretionary paid parental leave; backup care/family support and wellness tools; commuter benefits, tuition reimbursement, Lifestyle Spending Account.