Associate Director of Global Drug Safety and Pharmacovigilance
1 week ago
We are seeking an experienced Associate Director of Global Drug Safety and Pharmacovigilance to join our team at Genmab. As a key member of our Global Drug Safety and Pharmacovigilance department, you will be responsible for ensuring the safe and effective development and marketing of our products.
Key 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 the primary safety contact for other departments and ensure appropriate and timely handling of safety issues
- 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 monthly 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
- 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
- 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
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Plainsboro, New Jersey, United States Genmab Full timeJob SummaryWe are seeking an experienced Associate Director, Global Drug Safety and Pharmacovigilance to join our team at Genmab. As a key member of our Global Drug Safety and Pharmacovigilance department, you will be responsible for ensuring the safe and effective development of our products.Key ResponsibilitiesPerform safety reviews of adverse event...
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