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 MedDRA 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 Report) Serve on Safety Management Team and liaise with clinical study/project teams, Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees and other entities as needed Participate in the preparation and revision of company product labeling and RMP as appropriate Assist with preparation and review safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other safety documents Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements

Skills:

ICSR reviews in Argus safety database Completed quarterly signal evaluation forms Completed signal issue work-ups Completed aggregate reports Risk Management Plans Slide decks for Safety Management Team/Product Safety Committee meetings