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Safety Science Medical Director (Safety Science Leader level)
The Safety Science Medical Director will be responsible for all safety aspects of an overall program or a group of products and works independently, to enable benefit-risk assessment and safety risk management.
In this role you will:
Develop timely and scientifically sound clinical safety portions of a Product Development Plan (PDP), lead the the product safety strategy development for the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents (e.g., the Clinical Development Plan/CDP, Integrated Development and Commercialisation Process/IDCP, etc.)
Responsible for the safety components and co-responsibility for the benefit/risk components together with the Clinical representative
Responsible of any safety regulatory authority submissions (From IND applications, to Marketing Authorization Applications/MAAs, and renewal or risk management plan and periodic safety documents)
Accountable for signal detection, evaluation and decision-making across the lifecycle of the product, input for Drug Monitoring Committees (iDMC) and internal governance (Drug Safety Committee ?DSC) for important safety issues
Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals
Responsible for the ongoing PV and Risk Management planning for designated products by preparation of the safety surveillance strategy
Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures and other guidelines.
Completed MD degree and 2 or more years of drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry
Demonstrated team leadership in industry or academic setting
Strong orientation towards cross-functional teamwork
At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity