Sr. Director, Global Drug Safety

Found in: Appcast Linkedin GBL C2 - 2 weeks ago


Elizabeth, United States Adecco Full time

My client (a growing publicly traded commercial biopharma company) is seeking an experienced Sr. Director / Director, Global Drug Safety. The individual will report into the VP, Drug Safety and be responsible for all safety data across assigned products. This is a hands on, sole contributor role with no direct reports.


The role is remote with the ideal candidate living in the Northeast or Mid-Atlantic as you will need to travel to the NJ office 1 – 4 times a month (based on location).


Responsibilities:

  • Responsible for all safety data throughout the life cycle
  • Lead safety signal surveillance and aggregate data analysis
  • Develop the strategy and implementation of safety and benefit-risk management
  • Author and review safety documents (DSUR, PADER, PBRER) and Risk Management documents (RMPs)
  • Medical oversight to the vendors
  • Review and contribute to safety sections within clinical documents


Requirements:

  • MD
  • 5 – 10 years of drug safety experience within pharma or biopharma
  • Recent oncology experience (Lymphoma preferred)
  • Strong understanding of pharmacovigilance regulatory requirements
  • Knowledge of drug development, safety monitoring and risk/benefit analysis
  • Experience with individual case medical review, signal detection and evaluation, aggregate data review and safety labeling


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