Associate Director, Global Drug Safety & Pharmacovigilance Scientist
Genmab
August 14, 2026
Remote friendly (Princeton, NJ)
United States
Operations
Role
As an Associate Director of Drug Safety and Pharmacovigilance, you will join the Global Drug Safety and Pharmacovigilance department and be responsible for drug safety-related activities in close collaboration with Safety colleagues and cross-functional teams. This role has a global perspective and interacts with regulatory authorities and colleagues across Genmab sites.
Responsibilities
- Contribute to safety strategy and safety deliverables for assigned programs.
- Perform ongoing surveillance (including signal detection/evaluation) of clinical trials and post-marketing safety data.
- Serve as primary safety contact for other departments; ensure timely handling of safety issues.
- Provide safety review/input to Trial Protocols, eCRFs/CRFs, TMFs; Investigator’s Brochures; Subject Informed Consent.
- Contribute to HA requests and review submission documents.
- Develop/maintain product lifecycle safety documentation (e.g., Safety Assessment Reports, DSUR, PBRER, PSUR, PAER, RSI, ADR in CCDS/labels, RMP, ad-hoc safety responses).
- Plan and conduct Safety Committee and DMC activities.
- Conduct safety training for employees, CROs, investigators, and relevant site personnel.
- Participate in multidisciplinary teams (incl. Clinical Management Team) and contribute to tool/process development.
- Interact with safety/clinical CROs; perform sponsor oversight; process invoices; ensure regulatory compliance/reporting.
- Support review of Safety Data Exchange Agreements; collaborate with external partners.
- Monitor regulations/guidelines; assess impact on drug safety processes.
- Ensure compliance for audits/inspections; participate as required.
Requirements (Required/Preferred)
- HCP degree (e.g., RN/BSN/MSN, NP, PA, PharmD) and 5+ years pharma industry experience in drug safety & pharmacovigilance in clinical trial and post-marketing settings.
- Preferred: oncology experience and/or first-in-human trials.
- Experience authoring safety documents (signal assessment reports, DSUR, PBRER, RMP, RSI).
- Skilled in signal detection and managing safety information across sources.
- Experience with FDA/EMA regulations and ICH guidance for pharmacovigilance/risk management.
- Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding.
- Prefer experience with safety databases (Argus preferred).
- Documented global oversight of multiple trials; international stakeholder experience.
- Excellent English communication (written and spoken).
Benefits (US-based candidates)
- Salary band: $162,640.00–$243,960.00
- 401(k) match (100% on first 6%); health/dental/vision; voluntary plans; paid time off; 12 weeks discretionary paid parental leave; backup care and support resources; commuter benefits, tuition reimbursement, and Lifestyle Spending Account.
Application Instructions
- Apply via Genmab’s website (Job Applicant Privacy Notice referenced).
As an Associate Director of Drug Safety and Pharmacovigilance, you will join the Global Drug Safety and Pharmacovigilance department and be responsible for drug safety-related activities in close collaboration with Safety colleagues and cross-functional teams. This role has a global perspective and interacts with regulatory authorities and colleagues across Genmab sites.
Responsibilities
- Contribute to safety strategy and safety deliverables for assigned programs.
- Perform ongoing surveillance (including signal detection/evaluation) of clinical trials and post-marketing safety data.
- Serve as primary safety contact for other departments; ensure timely handling of safety issues.
- Provide safety review/input to Trial Protocols, eCRFs/CRFs, TMFs; Investigator’s Brochures; Subject Informed Consent.
- Contribute to HA requests and review submission documents.
- Develop/maintain product lifecycle safety documentation (e.g., Safety Assessment Reports, DSUR, PBRER, PSUR, PAER, RSI, ADR in CCDS/labels, RMP, ad-hoc safety responses).
- Plan and conduct Safety Committee and DMC activities.
- Conduct safety training for employees, CROs, investigators, and relevant site personnel.
- Participate in multidisciplinary teams (incl. Clinical Management Team) and contribute to tool/process development.
- Interact with safety/clinical CROs; perform sponsor oversight; process invoices; ensure regulatory compliance/reporting.
- Support review of Safety Data Exchange Agreements; collaborate with external partners.
- Monitor regulations/guidelines; assess impact on drug safety processes.
- Ensure compliance for audits/inspections; participate as required.
Requirements (Required/Preferred)
- HCP degree (e.g., RN/BSN/MSN, NP, PA, PharmD) and 5+ years pharma industry experience in drug safety & pharmacovigilance in clinical trial and post-marketing settings.
- Preferred: oncology experience and/or first-in-human trials.
- Experience authoring safety documents (signal assessment reports, DSUR, PBRER, RMP, RSI).
- Skilled in signal detection and managing safety information across sources.
- Experience with FDA/EMA regulations and ICH guidance for pharmacovigilance/risk management.
- Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding.
- Prefer experience with safety databases (Argus preferred).
- Documented global oversight of multiple trials; international stakeholder experience.
- Excellent English communication (written and spoken).
Benefits (US-based candidates)
- Salary band: $162,640.00–$243,960.00
- 401(k) match (100% on first 6%); health/dental/vision; voluntary plans; paid time off; 12 weeks discretionary paid parental leave; backup care and support resources; commuter benefits, tuition reimbursement, and Lifestyle Spending Account.
Application Instructions
- Apply via Genmab’s website (Job Applicant Privacy Notice referenced).