Medical Director, Global Drug Safety Product Leader (f/m), Darmst

On behalf of our successful client we are looking for a health director in Darmstadt asap.

Specific Job Description
The role of the Global Drug Safety Product Leader is to ensure effective proactive safety strategies for the assigned product(s) be it a development compound or a marketed product; delivery of safety aspects input to clinical development; and risk management and benefit-risk evaluation for the product. This includes delivery of the medical evaluation of single cases; singal detection and evaluation activities; all periodic safety reports, risk management plans and regulatory documents; ensuring definition, implementation of risk mitigation actions, and safety input to clinical trial activities as appropriate.
For the assigned product or products, either directlyor through effective delegation to other memebers of the GDS Product Team:

• ensure provision of a clearly defined safety strategy, in the context of delivering the benefit-risk profile, and ensure that plans in place are consistent with delivering this strategy;
• ensure appropriate oversight of the merging safety profile of the product, including review of individual safety cases, signal detection and evaluation, periodic reporting, risk-benefit evaluation and risk management, and that any significant signals or safety issues are escalated appropriately within the company;
• ensure delivery of safety aspects to clinical trial activities as appropriate
• maintain an appropriate level of knowledge about the product and the therapeutic area;
Please forward your CV to Tom Sander or via our web application system at www.randstad.de or by Mail. If you have any further questions please do not hesitate to contact Tom Sander.
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