Associate Director, Global Drug Safety

1 week ago

Princeton, New Jersey, United States Genmab AS Full time
Job Summary

We are seeking an experienced Associate Director, Global Drug Safety to join our team at Genmab A/S. 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 innovative antibody therapeutics.

Key Responsibilities
  • Perform safety review of Adverse Event reports for Genmab products
  • Conduct ongoing surveillance 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
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 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
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 we believe it is essential for our continued success.

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