Associate Safety Director

Associate Safety Director (m/f/d) – Freelance/temporary employment for a project in Basel Stadt, Start date: 08/26, Reference number: /1

Responsibilities

• Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRE).
• 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.
• Provide expert contribution to the development of the product safety strategy.
• Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB.
• In partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other int...

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