Associate Director, Global Drug Safety

2 days ago

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

We are seeking an experienced Associate Director to join our Global Drug Safety and Pharmacovigilance team in Princeton. As a key member of our team, you will be responsible for ensuring the safety of our products throughout their lifecycle, from clinical trials to post-marketing surveillance.

Key Responsibilities
  • Perform safety reviews of adverse event reports for Genmab products
  • Conduct ongoing surveillance of clinical trials and post-marketing safety data
  • Be the primary safety contact for other departments and ensure timely handling of safety issues
  • Provide safety input to various documents, including trial protocols, eCRFs/CRFs, and TMFs
  • Contribute to the development of safety-related documents, such as Investigator's Brochures and Subject Informed Consent
  • Collaborate with external experts and partners to ensure compliance with regulatory guidelines and internal processes
  • Perform ongoing surveillance of new and updated regulations/guidelines and assess their impact on drug safety processes
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
  • 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
About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. We are committed to fostering workplace diversity at all levels of the company and believe it is essential for our continued success.

We are committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website https://www.genmab.com/privacy.

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