Your mission
In this role you will lead the strategic direction for Clinical Drug Safety, overseeing the evaluation of the safety profile of our products throughout their lifecycle. You will also shape and implement safety standards and drive the overall safety strategy supporting our clinical development programs.
Responsibilities:
- Provide medical expertise and judgement in safety surveillance activities including periodic safety reports, safety signal detection, and in creation and updates of development risk management plans.
- Evaluate and manage risks associated with assigned projects and make recommendations for the management communication of risks, in accordance with global legal and regulatory frameworks.
- Lead the Signal Detection process for the CatalYm projects
- Provide Safety medical expertise and judgement in the production of...