Associate Safety Director (m/f/d)

Start Date: ASAP (Latest )
End Date: 12-month contract
Workload: 100%
Location: Basel (Hybrid possible)
Work model: Contracting

Your Tasks:

• Develop and maintain an understanding of the safety profile of the assigned product(s) or therapy areas. Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action).
• Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER).
• Responsible for signal detection and management activities. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (incl, product quality) or in response to Regulatory Authority requests.
• Provid...