Vice President – Pharmacovigilance

Vice President – Pharmacovigilance

Requirements

• BS/BA degree in health care science or related discipline and a minimum of twenty-one years of related experience; or,
• MS/MA degree in health care science related discipline and a minimum of nineteen years of related experience; or,
• MD, PharmD or PhD in related discipline and a minimum of seventeen years of related experience; or,
• Equivalent combination of education and experience
• 10 or more years of supervisory/management experience in a matrix and geographically dispersed pharmaceutical/biotechnology organization
• Working knowledge of and experience with domestic and international regulatory Adverse Event Reporting requirements
• Experience with pharmacovigilance data systems (Oracle Argus, signal detection, and data analytics tools)
• Leading and participating in GXP inspections

Responsibilities

• Responsible for leading and executing the strategy for PV Operations function in compliance with PV regulatory requirements for investigational and marketed compounds
• Oversight and management of Global Patient Safety Operations’ staff responsible for case management and ensuring process optimization, case quality, and accurate regulatory reporting
• Direct the handling of adverse events according to national and international regulatory reporting requirements and ensure timely, complete, and accurate submission of Individual Case safety reports to regulatory authorities in compliance with regulations.
• Accountable for the oversight of the operational activities with the PV vendors and Service Providers including the establishment of adequate standards/processes and of the tracking of the performance.
• Oversight of the safety data management strategy.
• Collaborate with Information Technology on implementation and maintenance of the global safety database and tools for data analytics and signal management
• Oversight for the prioritization, planning & execution of global reports, oversight of custom report development and ad hoc query development.
• Maintain oversight of the PV Quality Management System ensuring that systems and processes meet regulatory standards and ensures patient safety related to use of our products.
• Lead the development and maintenance of KPIs, processes and procedures for the Global Patient Safety function.
• Oversight of the management and maintenance of PV Agreements with PV Business partners.
• Ensure audit and inspection readiness in compliance with departmental processes and regulations
• Oversight of recommendations for corrective and preventive actions and tracking corrective action commitments until closure

Preferred Qualifications

• Extensive knowledge of biotechnology/pharmaceutical sector drivers and practices throughout the entire product lifecycle
• Extensive knowledge of US and international pharmacovigilance regulations, with experience in their practical application throughout the entire product lifecycle
• Demonstrates advanced skill and keen insight in gathering, analyzing, and applying key information to solve complex problems
• Demonstrates excellent organizational and planning capabilities by managing time, workload, and resources of a department
• Leads and manages multiple functional areas within a department to execute on team functional objectives to deliver results on common functional and departmental goals and to make decisions on behalf of department
• Demonstrates the highest standards of verbal and written communication. Demonstrates flexibility in selecting communication methods and media appropriate to the message and the audience. Speaks clearly and confidently in one-to-one situations and effectively presents to large audiences within and outside Exelixis.
• Creates formal networks to foster collaboration among internal and external groups and stakeholders. Encourages teamwork and collaboration within network.
• Excellent interpersonal skills and ability to incorporate differing views to resolve challenges and develop agreed upon resolutions
• Exhibits resilience in stressful, ambiguous or high-pressure situations
• Mentors junior team members.
• Leads departmental performance reviews and professional development planning process.