Merck Group - Lead - Safety Strategy

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.