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Merck Group - Lead - Safety Strategy (5-18 yrs)
Safety Strategy Lead
Your Role :
- To ensure the delivery of integrated medical safety strategy for compounds in early development including proactive surveillance, effective signal and benefit risk management.
- Ensure oversight of the emerging safety profile of the product, including medical review of individual case safety reports as required, signal detection and evaluation, periodic safety reporting
- Ensure that safety signals are identified promptly and communicated/escalated within the company appropriately
- Ensure high quality medical safety contributions to Pharmacovigilance Advisory Boards.
- Chair Benefit Risk Action Team and Safety Monitoring Committees as required
- Ensure effective communication of product-related aspects in audits and regulatory authority inspections.
- Represent GPS on cross-functional teams for the product
- Act as subject matter expert for HA interaction
- Closely collaborate with the Safety Strategy lead, as relevant.
- Able to demonstrate understanding and experience in managing safety in early development
Who you are : 5+ years of experience into the pharmaceutical industry.
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