Global Drug Safety Associate Director

2 days ago

Princeton, New Jersey, United States Genmab Full time
About the Role

Genmab is seeking an experienced Associate Director of Global Drug Safety and Pharmacovigilance to join our team in Princeton. As a key member of our Global Drug Safety and Pharmacovigilance department, you will be responsible for drug-related activities in close cooperation with Safety colleagues and cross-functional team members.

This is a global role, and you will interact with stakeholders ranging from regulatory authorities and colleagues from Genmab's four sites. You will be part of a highly skilled and international team, reporting to the Director, Global Drug Safety & Pharmacovigilance, Scientist Lead.

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 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 the product lifecycle, from FIH to post-marketing
  • 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 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 for audits and inspections
  • Participate in audit and inspection activities as required
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 reports, 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
About You

You are passionate about Genmab's purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment. You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving. You are a generous collaborator who can work in teams with diverse backgrounds. You are determined to do and be your best and take pride in enabling the success of Genmab.

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