Overview
Vice President, Global Patient Safety Operations (GPS). The VP GPS Operations oversees the global pharmacovigilance areas of Case Evaluation and Reporting (CER) and the Quality and Compliance Center of Excellence (CoE), ensuring effective operations and compliance across the portfolio lifecycle and geographies. This executive role requires a strategic business leader with experience in leading patient safety areas, team development, pharmacovigilance operations, quality and compliance, planning, and implementing regulatory requirements. The VP GPS Operations drives operational excellence, compliance, and continuous improvement of PV capabilities, operations, and compliance. The leader will develop a leadership team, oversee talent development, and serve on the GPS Leadership Team (LT).
Responsibilities
- Lead pharmacovigilance operations and delivery for GPS areas: CER (Case Evaluation and Reporting) and Q&C CoE (Quality and Compliance Center of Excellence).
- Provide strategic leadership and direction to the pharmacovigilance team, fostering a culture of excellence, efficiency, compliance, and continuous improvement, and strengthening inspection readiness.
- Collaborate with executive leadership to integrate pharmacovigilance strategies with broader company objectives and regulatory requirements for Regeneron’s portfolio.
- Provide PV leadership, expertise, and guidance to cross-functional teams to support product development, regulatory submissions, and post-marketing activities in case operations, PV quality and compliance, and planning.
- Deliver business excellence to improve efficiencies, optimize resource utilization, and provide strategic oversight of safety systems.
- Oversee and manage all aspects of pharmacovigilance activities, including adverse event reporting, signal detection, risk management, and benefit-risk assessments.
- Ensure timely and accurate submission of safety reports to regulatory authorities and maintain compliance with global PV regulations.
- Develop forecasting methods and optimize vendors and third-party partners to deliver efficiencies.
- Implement and manage robust pharmacovigilance systems and processes to ensure data integrity and quality.
- Stay current with global regulatory requirements, provide assessments to the GPS LT, and work with the QPPV Office to ensure compliance with PV regulations and guidelines.
- Strengthen PV readiness for inspections and audits.
- From an operations perspective, meet stakeholder needs including Global Development, Industrial Operations and Product Supply (IOPS), Commercial, and Business Development.
- Collaborate with all GPS functions (Safety Sciences, Pharmacoepidemiology and Risk Management CoE, QPPV Office) and Regeneron departments (GD quality, vendor management, medical affairs, regulatory affairs) to ensure seamless integration of PV activities and objectives.
- Provide PV expertise and mentorship to cross-functional teams for product development, regulatory submissions, and post-marketing activities.
- Establish and monitor department KPIs and PV vendor metrics.
Qualifications
- Advanced degree in life sciences, pharmacy, medicine, or a related field (MD, PharmD, PhD preferred).
- Minimum of 20 years of experience in pharmacovigilance within the biotech or pharmaceutical industry.
- Extensive knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).
- Proven track record of leadership and strategic management, with team development in pharmacovigilance.
- Strong understanding of drug development processes and post-marketing surveillance.
- Excellent communication, interpersonal, and organizational skills.
- Ability to work collaboratively in a fast-paced, dynamic environment; strong business acumen and ability to collaborate across all organizational levels.
Salary and Benefits
Salary Range (annually): $300,000.00 - $500,000.00
Additional Details
- Seniority level: Executive
- Employment type: Full-time
Regeneron is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the company's business.
Please note that background checks may be conducted in accordance with applicable laws in the country where the position is based, including identity, right to work, and educational qualifications.
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