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

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Job ID:00392968Job349of371US Pharmacovigilance (USPV) ManagerSouth San Francisco, CaliforniaJob factsJob functionDrug SafetyLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelManagerServiceDirect 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 PositionSummary of Position:Responsible for the leadership and management of USPV activities which include (but not limited to) safety support for: PD and gRED study management teams; the Americas regional Affiliates; US Medical Affairs studies and programs; training and quality initiatives. These responsibilities are performed under the direction of the Head, US Pharmacovigilance.Job Duties/Responsibilities:* Accountable for the design and implementation of strategic, operational and personnel plans for assigned USPV and PD/gRED-related activities. This includes the intake and submission of spontaneous reports and safety support and direction for both the clinical trial teams and US Medical Affairs teams for non-interventional studies and programs.* Participates in the creation of the organizational strategy, goals, and objectives for the department, and assists in the implementation of the business plans to support both local and global safety strategies (i.e., rollout of new safety initiatives, implementation of new Health Authority safety requirements).* Collaborates with other PDS departments (e.g., training) to provide expertise and guidance to personnel for interdepartmental and cross-functional team activities, including process improvement standards and metrics.* Interact with the Americas Affiliates as required to address safety queries, share best practices, and discuss new safety regulations.* Oversight of PV activities related to licensing partners.* Through coordination with the PV Compliance Group will ensure appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits.* Accountable for coaching and developing direct reports by providing an environment that encourages ongoing personal and professional development. Will also be expected to further develop own potential succession candidate.* Responsible for the performance of assigned personnel against departmental processes, standards and performance goals, and for ensuring successful completion of all training required for the role.Competencies Identified for Success:

KEY REQUIREMENTS:

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