The Vice President (VP) of GPS Operations is responsible for overseeing 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 our portfolio lifecycle and geographies.
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This executive role requires a strategic business leader with experience in leading patient safety areas, proven abilities in team development, an in-depth understanding of pharmacovigilance operations, quality and compliance, planning, and assessing and implementing regulatory requirements, along with shown capabilities to lead cross-functional initiatives. The VP of GPS Operations will drive operational excellence, compliance, and continuous improvement of globalization and innovation of PV capabilities, operations, and compliance. This leader will develop a leadership team, provide oversight of talent development, and join the GPS Leadership Team (LT).
A typical day as a Vice President, Patient Safety Operations might look like :
- This leadership position is responsible for all aspects of pharmacovigilance operations and delivery in support of team areas of GPS :
CER (Case Evaluation and Reporting)
Q&C CoE (Quality and Compliance Center of Excellence)Provide strategic business 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 applicable initiatives on behalf of Regeneron’s portfolio and regulatory requirements.Provide pharmacovigilance leadership, expertise, and guidance to cross-functional teams to support product development, regulatory submissions, and post-marketing activities in the areas of 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 pharmacovigilance regulations.Develop forecasting methods and critical methods to optimize vendors and third-party partners to deliver efficiencies.Implement and manage robust pharmacovigilance systems and processes to ensure the highest standards of data integrity and quality.Keep abreast of global regulatory requirements, including providing assessments to the GPS LT and working in partnership with the QPPV Office to ensure compliance with all relevant pharmacovigilance regulations and guidelines.Strengthen all aspects of pharmacovigilance for readiness and inspections and audits.From an operations perspective, meet stakeholder needs including but not limited to Global Development, IOPS (Industrial Operations and Product Supply), Commercial, and Business Development.Collaborate with all areas of GPS : Safety Sciences, Pharmacoepidemiology and Risk Management CoE, QPPV office, etc., along with Regeneron areas including GD quality, vendor management, medical affairs, regulatory affairs, and other relevant departments to ensure seamless integration of pharmacovigilance activities and objectives.Provide PV expertise and mentorship to cross-functional teams to support product development, regulatory submissions, and post-marketing activities.Establish and ensure department Key Performance Indicators (KPIs) and PV vendor metrics.This role might be for you if :
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, 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 proven ability to collaborate across all organizational levels.Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and 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.
Salary Range (annually)
300,000.00 - $500,000.00
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Salary : $300,000 - $500,000
