Senior Director, Global Drug Safety and Pharmacovigilance

2 weeks ago


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

We are seeking a highly skilled and experienced Senior Director, Global Drug Safety and Pharmacovigilance to join our team at Genmab. As a key member of our organization, you will be responsible for leading our global safety strategy and ensuring the overall safety profile of our assigned products throughout their lifecycle.

Key Responsibilities
  • Develop and implement global safety strategies to ensure the safe use of our products
  • Lead cross-functional teams to identify and mitigate safety risks
  • Collaborate with regulatory authorities to ensure compliance with global regulations
  • Develop and maintain safety reports and documents
  • Provide medical expertise to support product development and commercialization
Requirements
  • MD degree with clinical research and/or fellowship training in oncology/hematology, pharmacology, or other relevant specialty
  • Minimum 10 years of experience in drug safety/pharmacovigilance with 2 years of clinical development experience
  • Excellent understanding of global PV regulatory environment
  • Strong knowledge of individual adverse event case report processing, triage, and medical review
  • Working knowledge of safety databases and electronic data capture systems
About Genmab

Genmab is an international biotechnology company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. We are passionate about our purpose and strive to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSOTM) antibody medicines.



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