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.