Associate Director, Global Drug Safety & Pharmacovigilance Scientist
About the position Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases. Genmab is on an ambitious growth path and to support this growth Genmab is looking for an additional Global Drug Safety (DS) and Pharmacovigilance (PV) Scientist to join the team in Princeton. As an Associate Director of Drug Safety and Pharmacovigilance, you will become part of the Global Drug Safety and Pharmacovigilance department, where you will be responsible for drug related activities in close cooperation with Safety colleagues along with cross-functional team members. This position has a global perspective, and you will interact with stakeholders ranging from regulatory authorities and colleagues from Genmab’s four sites. As an Associate Director of Drug Safety and Pharmacovigilance you will be part of a highly skilled and international team. The position reports to the Director, Global Drug Safety & Pharmacovigilance, Scientist Lead.
- Responsibilities
- Contribute to the development of safety strategy and safety deliverables for assigned programs for assigned programs in close collaboration with key stakeholders from GDS&PV and other cross functional teams
- Perform ongoing surveillance (including signal detection/evaluation) of Genmab clinical trials and post marketing safety data
- Be the primary safety contact for other departments and ensure appropriate and timely handling of safety issues for assigned trials/programs
- Provide safety review and input to various documents including but not limited to: Trial Protocols, eCRFs/CRFs, and TMFs
- Contribute to the development of other documentation such as: Investigator’s Brochures, and Subject Informed Consent
- Contribute to HA requests and review key submission documents
- Contribute to safety-related documents for Genmab products throughout product lifecycle from FIH to post-marketing, including robust safety surveillance, Safety Assessment Reports for potential signals/risks, RSI in IB, ADR in the CCDS and product labels, Aggregate Safety Reports (e.g. DSUR, PBRER, PSUR, PAER), RMP, and responses to ad-hoc requests for safety information internally and externally
- Contribute to the planning and conduct of Safety Committee activities and DMC’s
- Conduct safety training of Genmab employees, CROs, Investigators and other relevant site personnel as necessary
- Contribute to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products
- Contribute to the development and optimization of new tools and process
- Interact with safety and clinical CROs, perform sponsor oversight activities for safety related tasks, process invoices, and ensure regulatory compliance (including regulatory reporting requirements) for assigned products
- Support review of Safety Data Exchange Agreements with partners as required
- Collaborate with external experts and partners
- Perform ongoing surveillance of new and updated regulations/guidelines and assess the impact on drug safety processes at Genmab
- Ensure compliance with regulatory guidelines and internal processes and procedures in preparation of 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 within the field of oncology is preferred and/or first human trials
- Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI
- Skilled in signal detection process and managing safety information from clinical development and post-marketing sources
- Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management
- Knowledge of drug development process, pharmacovigilance databases and MedDRA coding
- Experience with use of safety databases, preferably Argus Safety Database
- Documented experience from overseeing multiple trials with safety inputs at the Global level
- International experience from a similar role with internal and external stakeholders
- Excellent communication skills in English both written and spoken
- Strong communicator and good at building professional relations with collaborators and business partners.
- You are proactive and able to prioritize work in a fast paced and changing environment
- You are result-and goal-oriented and committed to contributing to the overall success of Genmab
- Nic