Position Description:
The Vice President, Drug Safety (VP) position is responsible for determining the strategy for managing all operational processes and information systems supporting the global Drug Safety and Pharmacovigilance (PV) function within Exelixis and its partners. This leadership position oversees the management of the Exelixis drug safety operations team and the Contract Research Organization who handle safety data from receipt to submissions, system operations, and quality management system. The VP also manages all compliance operations functions. The VP's organization also maintains a PV quality system for compliance monitoring. The VP should possess a strong knowledge of global pharmacovigilance regulations, operational efficiencies, information systems, and industry practices to effectively solve challenges and facilitate PV compliance.

Position Requirements:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Drug Safety Operations:
• Determine data management strategy for the global safety database including the allocation of case processing tasks between Drug Safety operations and Contract Research Organization (CRO) staff.
• Manage and direct Drug Safety operations staff to oversee case management functions ensuring process optimization, cases quality, and accurate regulatory reporting
• Optimize utilization of information systems supporting case management (e.g., Oracle Argus).
• Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis.
• Determine processes and/or tools supporting Pharmacovigilance signal management in accordance with EMA GVP Module IX.

Quality Management:
• Ensure compliance of the PV system for all safety data sources in collaboration with Exelixis cross functional stakeholders including the Medical Affairs and Commercial, and business partners
• Identify procedures for monitoring compliance with drug safety-related policies, procedures, applicable regulations, and agreements with contractual partners
• Establish and measure key compliance, quality and performance indicators (KCI/KQI/KPIs) for the drug safety department
• Plan, conduct and document internal and external GVP audits to assess compliance with applicable regulations, regulatory commitments, company SOPs, protocols and contractual obligations as applicable
• Provide recommendations for corrective and preventive actions and tracking corrective action commitments until closure
• Manage the operational compliance for partnership, participate in and support audits of contractual partners as necessary.
• Act as the Drug Safety operations representative in various Company-wide committees.
• Oversight of Department Process and Project Management Efforts:
• Proactively identify procedural gaps and challenges and propose/implement solutions, lead the establishment of business process optimization efforts to ensure efficiency and process improvements with the department.
• Formulate controls to maintain a system of third-party vendors to ensure compliance with PV reporting requirements.
• Lead the establishment of a business process optimization function to ensure efficiency and process improvement.
• Identify and develops functions to manage a portfolio of projects geared towards the achievement of business objectives while adhering to agreed scope, time, quality and budget and oversee preparation of inspection readiness and manage/participate in the audits of business partners.
• Define operational strategy for upcoming initiatives including innovative drug combinations and new partnerships.

Functional Oversight:
• Develops operating plans and budgets and allocate resources to ensure budgets, schedules and performance requirements are met.
• Model the Exelixis Values including promoting collaboration at all levels of the organization.

SUPERVISORY RESPONSIBILITIES:
• Will supervise employee(s) directly and indirectly through a dotted line structure or via other subordinate supervisors

EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline and twenty years of related experience; or
• MS/MA degree in related discipline and eighteen years of related experience; or,
• PhD, MD, or PharmD in related discipline and sixteen years of related experience, or
• Equivalent combination of education and experience.

Experience:
• Related experience should include 10 or more years of supervisory/management experience in a matrix and geographically dispersed organization.

Knowledge/Skills/Abilities:
• Demonstrated excellent organizational and planning capabilities - Excellent critical data analysis skills (clinical/systems/processes/compliance)
• Demonstrated excellent teamwork, collaboration and interpersonal skills - Demonstrated leadership skills including significant managerial experience, team motivation, collaborative interaction, ability to problem-solve, prioritize, take initiative, meet challenges
• Excellent communication skills (oral/written)
• In-depth knowledge of US and international pharmacovigilance regulations (e.g. EU PV Legislation), FDA requirements, international guidelines (ICH/CIOMS) with experience in their practical application.
• In-depth understanding of pharmacovigilance processes, regulatory compliance and standardization.
• Pharmacovigilance data systems (Oracle Argus, signal detection, and data analytics tools) experience is required.

JOB COMPLEXITY:
• Works on very complex problems where analysis of situations or data requires an in-depth evaluation of various factors. May work on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Creates formal networks involving coordination among groups.

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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