Job Description
Role
Associate Director of Drug Safety and Pharmacovigilance – Princeton, NJ.
Responsibilities
- Contribute to development of safety strategy and deliverables for assigned programs, collaborating with stakeholders across GDS/PV and cross‑functional teams.
- Perform ongoing surveillance, including signal detection and evaluation, of Genmab clinical trials and post‑marketing safety data.
- Serve as primary safety contact for other departments, ensuring timely handling of safety issues.
- Provide safety review and input to key documents such as Trial Protocols, eCRFs/CRFs, TMFs, Investigator’s Brochures, and Subject Informed Consent.
- Contribute to submission documents for HA requests and key regulatory dossiers.
- Develop safety‑related documents throughout product lifecycle, including robust safety surveillance, Safety Assessment Reports, RSI in IB, ADR in CCDS, product labels, Aggregate Safety Reports (DSUR, PBRER, PSUR, PAER), RMP, and responses to ad‑hoc safety requests.
- Plan and conduct Safety Committee activities and Data Monitoring Committee (DMC) meetings.
- Deliver safety training to Genmab employees, CROs, investigators, and site personnel.
- Participate in multidisciplinary project groups, including membership of the Clinical Management Team (CMT).
- Develop and optimize new tools and processes for drug safety management.
- Oversee safety activities with safety and clinical CROs, perform sponsor oversight, process invoices, and maintain regulatory compliance, including regulatory reporting requirements.
- Support review of Safety Data Exchange Agreements with partners.
- Collaborate with external experts and partners to keep abreast of new regulations and assess impact on drug safety processes.
- Ensure compliance with regulatory guidelines and internal procedures in preparation for audits and inspections.
- Participate in audits and inspections as required.
- Other duties as assigned.
Requirements
- Health Care Professional degree required (RN/BSN/MSN, NP, PA, PharmD) and ≥5 years of pharmaceutical industry experience in drug safety & pharmacovigilance.
- Experience in oncology and/or first‑human trials preferred.
- Experience authoring safety signal assessment reports, DSUR, PBRER, RMP, and RSI.
- Skilled in signal detection processes and managing safety information from clinical development and post‑marketing sources.
- Experience with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management.
- Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding.
- Experience with safety databases, preferably Argus.
- Documented experience overseeing multiple trials with safety inputs at a global level.
- International experience in a similar role managing internal and external stakeholders.
- Excellent written and spoken English communication skills.
- Strong communicator with ability to build professional relationships.
- Proactive, able to prioritize work in a fast‑paced and changing environment.
- Result‑oriented and committed to contributing to Genmab’s success.
Benefits
- 401(k) Plan: 100% match on first 6% of contributions
- Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
- Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
- Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
- Support Resources: Child and adult backup care, family support programs, financial wellness tools, and emotional well‑being support
- Additional Perks: Commuter benefits, tuition reimbursement, and Lifestyle Spending Account
Salary
US based salary band: $162,640.00—$243,960.00 (subject to individual factors).
Locations
Princeton, NJ, USA (hybrid work options available).
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