Associate Director Safety Science - Compass Consulting Group : Job Details

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. Duties: Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving BioMarin products to ensure accuracy of ICSR Med. DRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting Assist in follow-up of important ICSRs to ensure relevant information is sought Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists to identify, evaluate and manage safety signals Participate in the development development of safety surveillance and risk management plans for drug development programs Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR (PBRER format), US PADER, Annual Safety Report, DSUR, IND Annual Rep...Director, Science, Associate, Safety, Clinical, Regulatory Affairs, Manufacturing, Staffing