Vice President Safety Pharmacovigilance

2 months ago


Redwood City, United States SciPro Full time

SciPro has partnered with a leading Cell Therapy Biotech seeking a VP, Safety, and Pharmcovilignace to lead all safety initiatives for their clinical studies. The role will report directly to the CMO and work with cross-function teams across the business.



Role responsibilities:


  • Supervising the safety aspects of clinical trials, including the creation of safety monitoring plans and the analysis of data.
  • Evaluating emerging safety data, ensuring effective risk communication, and devising strategies to manage and minimize risks.
  • Developing and implementing pharmacovigilance strategies.
  • Compiling aggregate safety reports, such as Development Safety Update Reports (DSURs), reporting Serious Adverse Events (SAE) to Health Authorities, and addressing other safety-related aspects of regulatory filings.
  • Leading the safety team, providing necessary training and ongoing guidance, and managing direct staff, including conducting annual performance reviews.



Position Requirements:


  • Medical Doctor (MD) or equivalent degree, with experience in safety and pharmacovigilance
  • Must have experience in Oncology
  • Global experience in clinical trials and post-marketing settings (preferably in oncology/cell therapy).
  • Familiarity with global regulatory filings.
  • Exceptional organizational skills with the ability to prioritize effectively and deliver results within tight deadlines, independently or as part of a team.



If you are open to learning more about the role, please apply and I will be happy to set up a time to connect.



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