Associate Director Safety Science

Description

The Associate Director Safety Science performs signal detection activities, prepares aggregate safety reports, reviews ICSRs, and works with cross-functional team to evaluate safety signals.

Scope

• Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving company 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.

Deliverable (please have experience with)

• 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.