Vice President, Pharmacovigilance

SUMMARY/JOB PURPOSE:

The Vice President, Pharmacovigilance provides strategic leadership, management and oversight of case management, operational processes, the quality management system, compliance operations and monitoring; and safety systems for the Exelixis Global Patient Safety Department and its partners. In addition, this role oversees the case management and related operational activities of the Contract Research Organization. Ensures that all activities are consistent with global regulatory requirements and Exelixis’ operating processes, procedures, regulatory, and legislative requirements. Member of the Global Patient Safety Senior Leadership Team.

ESSENTIAL DUTIES AND 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 overisght of the PV Quality Management System ensuring that systems and processes meet regulatory standards and ensures pateint 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

Functional Oversight:

• In collaboration with Global Patient Safety Leadership Team, develops operating plans and budgets and allocate resources to ensure budgets, schedules and performance requirements are met.

• Models the Exelixis Values including promoting collaboration at all levels of the organization.

SUPERVISORY RESPONSIBILITIES:

• Supervises employees directly and indirectly through a dotted line structure or via other subordinate supervisors

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• 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

Experience/The Ideal for Successful Entry into Job:

• Related experience should include 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) experience

• Leading and participating in GXP inspections

Knowledge/Skills:

• 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 hallenges 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.

JOB COMPLEXITY:

• Capable of strategically and proactively assessing workload, trends, tasks, and priorities for cross-functional activity

• Plans and executes multiple projects or activities, throughout the department, removing barriers and considering alternative methods and contingency plans to avoid potential issues and promote efficiency

• Designs and implements solutions to address departmental and cross functional challenges, taking into consideration the broader impact

• Engages, influences, and collaborates with stakeholders on cross-functional projects of increased corporate importance

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