Associate Director, Global Drug Safety & Pharmacovigilance Scientist
Genmab
June 29, 2026
Remote friendly (Princeton, NJ)
United States
Medical Affairs
Responsibilities:
- Contribute to safety strategy and safety deliverables for assigned programs in collaboration with cross-functional teams.
- Perform ongoing surveillance (including signal detection/evaluation) of clinical trials and post-marketing safety data.
- Serve as primary safety contact to ensure appropriate handling of safety issues.
- Provide safety review/input to Trial Protocols, eCRFs/CRFs, and TMFs; contribute to Investigator’s Brochures and Subject Informed Consent.
- Contribute to safety-related lifecycle documents (e.g., DSUR, PBRER, PSUR, PAER, RMP) and responses to ad-hoc safety requests.
- Support Safety Committee and DMC activities; conduct safety training; develop/optimize tools and processes.
- Oversee sponsor/safety-related activities with CROs; ensure regulatory compliance and reporting; support audits/inspections.
Requirements:
- HCP degree (e.g., RN/BSN/MSN, NP, PA, PharmD) and 5+ years pharmaceutical drug safety & pharmacovigilance experience as a Safety Scientist (clinical trial and post-marketing).
- Oncology experience preferred and/or first-in-human trials.
- Experience authoring safety signal assessment reports, DSUR, PBRER, RMP, RSI.
- Skilled in signal detection and managing safety information; knowledge of FDA/EMA and ICH guidance; MedDRA coding.
- Safety database experience (preferably Argus) and global trial oversight experience.
- Excellent English communication (written/spoken).
US benefits (within first year for regular full-time employees): 401(k) match; medical/dental/vision; paid time off and 12 weeks paid parental leave; backup care, family support, financial wellness and emotional wellbeing resources; commuter benefits, tuition reimbursement, Lifestyle Spending Account.
- Contribute to safety strategy and safety deliverables for assigned programs in collaboration with cross-functional teams.
- Perform ongoing surveillance (including signal detection/evaluation) of clinical trials and post-marketing safety data.
- Serve as primary safety contact to ensure appropriate handling of safety issues.
- Provide safety review/input to Trial Protocols, eCRFs/CRFs, and TMFs; contribute to Investigator’s Brochures and Subject Informed Consent.
- Contribute to safety-related lifecycle documents (e.g., DSUR, PBRER, PSUR, PAER, RMP) and responses to ad-hoc safety requests.
- Support Safety Committee and DMC activities; conduct safety training; develop/optimize tools and processes.
- Oversee sponsor/safety-related activities with CROs; ensure regulatory compliance and reporting; support audits/inspections.
Requirements:
- HCP degree (e.g., RN/BSN/MSN, NP, PA, PharmD) and 5+ years pharmaceutical drug safety & pharmacovigilance experience as a Safety Scientist (clinical trial and post-marketing).
- Oncology experience preferred and/or first-in-human trials.
- Experience authoring safety signal assessment reports, DSUR, PBRER, RMP, RSI.
- Skilled in signal detection and managing safety information; knowledge of FDA/EMA and ICH guidance; MedDRA coding.
- Safety database experience (preferably Argus) and global trial oversight experience.
- Excellent English communication (written/spoken).
US benefits (within first year for regular full-time employees): 401(k) match; medical/dental/vision; paid time off and 12 weeks paid parental leave; backup care, family support, financial wellness and emotional wellbeing resources; commuter benefits, tuition reimbursement, Lifestyle Spending Account.