Associate Safety Director

(m/f/d)

Freelance/Contracting project Basel Stadt Start date: 08/26 Reference number: /1

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Responsibilities

Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting ( 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 Co...