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Job Field: Security
Location: United States, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Job ID:00400012Job356of371Safety Science Leader (MD) - OncologySouth San Francisco, CaliforniaJob factsJob functionDrug SafetyLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExperiencedServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionPurpose: The Safety Science Leader (SSL) is accountable for all aspects of safety related to a product in the Life Cycle Team (LCT) stage including single case assessment, aggregate reporting, signal detection, risk management throughout the life cycle. The Safety Science Leader leads product specific safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate. Accountability is partially exerted by the bringing of safety topics to the Development Subteam (DST) and, when appropriate, the Life Cycle Team (LCT) to ensure that adequate safety measures are implemented, based on data, and that CIOMS 6 guidelines are followed. Primary Responsibilities and Accountabilities:* Contributes to scientific publications (abstracts, posters, papers) for scientific meetings/journals and approves submissions from a safety perspective. * Reviews all communications to the public from a safety point of view. * Keeps the EU QPPV fully informed of any changes to the benefit-risk relationship and, where appropriate, performs tasks as delegated by the EU QPPV. * With the CSL and the DST, plans and performs, on an ongoing basis, an evaluation of the safety data to detect safety signals. On an ongoing basis with the team, evaluates the Benefit/risk relationship of the program and determines how to manage patients within and across trials.* Is accountable for safety components of all NDA documents. * Is responsible for the writing and maintenance of RMP/REMS NDA documents. * Represents Roche in interactions with Health Authorities and Independent Data Safety Monitoring Boards (ie Pre-BLA/NDA meetings, advisory committees) for safety related topics. * Contributes to and where specifically delegated may be responsible for the proper execution of the post-approval RMP/REMS * Ensures that all safety processes are properly supported and compliance is documented for all studies conducted by PD or PB or affiliates. People Leadership: * Provides provide leadership and line management to the Safety Sciences department across multiple locations, aligning with other parts of the organization, where necessary. * Ensures that the performance of direct reports is proactively managed and that they are coached, trained and developed to maximize their contributions. * Allocates resources and is accountable for the assignment of his/her collaborators / reports according to their individual capabilities and in line with projects priorities.* Ensures that staff communication and employee relations are managed proactively to maximize the well being of employees. * Actively installs the Roche values in the Safety Team and their activities.Who You AreEducation Minimum: Physician who would be eligible for medical practice in EU or in US Strongly desired: Post doctorate experience in a specialty such as internal medicine, pediatrics, or geri

KEY REQUIREMENTS:

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