The Drug Safety Fellowship program is designed to provide hands-on experience in safety surveillance, including assimilating and assessing safety information, signal detection, and risk management, for small molecule/biologic products at various stages of development. Under the mentorship of the Fellowship Preceptor and senior leadership, the fellow will have the opportunity to undertake key responsibilities within Drug Safety and Pharmacovigilance, including (but not limited to):
––Safety data aggregation
––Signal detection and evaluation
––Risk management and minimization planning
––Strategic safety messaging and authoring of aggregate reports
––Safety content development for clinical trial documents
––Global/regional PV regulations (ICH, FDA, etc.) and safety database training
––Individual case safety report processing and medical content review
––Cross-functional safety committee presentation
––Safety-related health authority response writing
As the fellow achieves competency in the Drug Safety and Pharmacovigilance department, they will have the opportunity to gain experience in other functional areas of interest, such as but not limited to Medical Affairs, Medical Information, Regulatory Affairs, Clinical Development, Pharmacovigilance Operations and Quality.
Over the course of 2 years, fellows will experience a comprehensive training program with gradual development of skills and technical capabilities. The first year focuses on the fundamentals of drug safety and pharmacovigilance. The second year offers the fellow to assume more responsibility and contribute independently on projects with the option to rotate across different functional areas that complement drug safety. The following is a snapshot of what can be expected in the 1st and 2nd years of the fellowship:
Year 1:
––Developing an understanding of pharmacovigilance operations and regulations for individual case processing and medical review
––Developing an understanding of drug safety including signal detection, safety evaluation and risk management activities
––Assist with the coordination of the Signal Detection and Safety Management teams and activities for assigned product
––Participating in data assimilation for aggregate safety reports (e.g. DSUR, PADER, RMP, etc.)
––Reviewing safety sections of clinical trial documents (i.e. IB, protocol, informed consent form, and other study-specific documents) ensuring accuracy and consistency
––Presenting on a related drug safety topic to department and other key stakeholders
Year 2:
––Leading Signal Detection and Safety Management teams and activities for assigned product
––Assume responsibility for the safety for one or more study protocols and represent Drug Safety & Pharmacovigilance at cross-functional meetings
––Authoring safety sections of clinical trial documents (i.e. IBs, protocol, informed consent form, and other study-specific documents)
––Driving the process, providing contributions, and authoring aggregate reports (e.g. DSUR, PADER, RMP, etc.)
––Participate in generating responses to safety-related health authority queries and contributing safety content for regulatory submission filings
––Optional: One to two 3-month rotations in other areas of interest.
