Senior Manager, Global Drug Safety & Pharmacovigilance Scientist

Role Summary

Senior Manager, Global Drug Safety & Pharmacovigilance, Scientist. Genmab is seeking an experienced Global Drug Safety (DS) and Pharmacovigilance (PV) Scientist to join the team in Princeton. The role involves global drug safety activities in collaboration with Safety colleagues and cross-functional teams, interacting with regulatory authorities and Genmab sites. The position reports to the Director, Global Drug Safety & Pharmacovigilance, Scientist Lead. This is a hybrid role requiring 60% in-office presence.

Responsibilities

• Perform safety review of Adverse Event reports for Genmab products
• Perform ongoing surveillance (including signal detection/evaluation) of Genmab clinical trials and post marketing safety data
• Be a primary safety contact for other departments and ensure appropriate and timely handling of safety issues for assigned clinical trials
• Provide safety review and input to various documents including Trial Protocols, eCRFs/CRFs, and TMFs
• Contribute to development of Investigator‚Äôs Brochures and Subject Informed Consent
• Contribute and support health authority requests and review key submission documents
• Contribute to safety-related documents throughout product lifecycle (monthly safety surveillance, Safety Assessment Reports, RSI in IB, ADR in CCDS, product labels, DSUR/PBRER/PSUR/PAER, RMP, ad-hoc safety responses)
• Contribute to Safety Committee activities and DMCs
• Conduct safety training for Genmab employees, CROs, Investigators, and site personnel
• Contribute to multidisciplinary project groups including Clinical Management Team (CMT) for assigned products
• Develop and optimize new tools and processes
• Interact with safety and clinical CROs, oversee safety-related tasks, manage invoices, and ensure regulatory compliance for assigned products
• Support review of Safety Data Exchange Agreements with partners
• Collaborate with external experts and partners
• Monitor evolving regulations/guidelines and assess impact on drug safety processes
• Ensure compliance with regulatory guidelines and internal processes in audits and inspections; participate in audits/inspections as required
• Other duties as assigned

Qualifications

• Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PA, PharmD) with 3‚Äì5 years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in clinical trial and post-marketing environments
• Experience in oncology is preferred
• Experience in reviewing and authoring safety signal assessment reports, DSUR, PBRER, RMP, RSI
• Skilled in signal detection 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, pharmacovigilance databases, and MedDRA coding
• Experience with safety databases, preferably Argus Safety Database
• Experience overseeing multiple trials with safety inputs at the Global level
• International experience with internal and external stakeholders
• Excellent English communication skills (written and spoken)

Skills

• Strong communication and relationship-building with collaborators and partners
• Proactive, able to prioritize in a fast-paced environment
• Result- and goal-oriented with commitment to Genmab‚Äôs success

Education

• Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PA, PharmD) as stated above