Associate Director, Global Drug Safety & Pharmacovigilance Scientist

Role Genmab is on an ambitious growth path and is seeking an Associate Director of Drug Safety and Pharmacovigilance to join the team in Princeton. In this role you will be part of the Global Drug Safety and Pharmacovigilance department, responsible for drug‑related activities in close cooperation with safety colleagues and cross‑functional team members. The position has a global perspective and involves interacting with stakeholders including regulatory authorities and colleagues from Genmab's four sites. This role reports to the Director, Global Drug Safety & Pharmacovigilance, Scientist Lead. Responsibilities Contribute to the development of safety strategy and safety deliverables for assigned programs in close collaboration with key stakeholders from GDS&PV and other cross‑functional teams. Perform ongoing surveillance, including signal detection and evaluation, of Genmab clinical trials and post‑marketing safety data. Serve as the primary safety contact for other departments and ensure timely handling of safety issues for assigned trials/programs. Provide safety review and input to documents such as trial protocols, eCRFs/CRFs, TMFs, Investigator’s Brochures, and Subject Informed Consent. Contribute to the development of documents for regulatory submissions, including HSAs, RSIs in IB, ADR in CCDS, product labels, and safety assessment reports for potential signals/risks. Prepare aggregate safety reports (DSUR, PBRER, PSUR, PAER), risk‑management plans, and respond to ad‑hoc requests for safety information internally and externally. Plan and conduct Safety Committee activities and Data Monitoring Committees. Conduct safety training for Genmab employees, CROs, investigators, and other site personnel. Participate in multidisciplinary project groups, including membership on the Clinical Management Team (CMT) for assigned products. Develop and optimise new tools and processes related to drug safety. Interact with safety and clinical CROs, performing sponsor oversight activities, processing invoices, and ensuring regulatory compliance, including regulatory reporting requirements. Support review of Safety Data Exchange Agreements with partners as required. Collaborate with external experts and partners. Surveil new and updated regulations/guidelines, assess impact on drug safety processes at Genmab. Ensure compliance with regulatory guidelines and internal processes in preparation for audits and inspections. Participate in audit and inspection activities as required. Other duties as assigned. Requirements Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PA, PharmD) and 5+ years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post‑marketing environments. Experience in oncology is preferred and/or experience with first human trials. 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 Safety Database. Documented experience overseeing multiple trials with safety inputs at the global level. International experience in a similar role with internal and external stakeholders. Excellent communication skills in English, both written and spoken. Strong communicator and able to build professional relationships with collaborators and business partners. Proactive and able to prioritize work in a fast‑paced and changing environment. Result‑and goal‑oriented and committed to contributing to the overall success of Genmab. Benefits 401(k) Plan: 100% match on the 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: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well‑being support. Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses. Salary For U.S. based candidates, the proposed salary band for this position is $162,640.00—$243,960.00. The actual salary offer will be determined based on skills, qualifications, experience, location, and other factors. Location Genmab offers an open, agile working environment with offices across North America, Europe, and Asia Pacific, with the option for remote work where appropriate. #J-18808-Ljbffr