Regeneron Pharmaceuticals
Associate Director, PV Case Operations
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Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our PV Case Operations team.
Responsibilities:
- Providing oversight of pharmacovigilance (PV) operations in the successful management of vendor and case processing deliverables in accordance with applicable regulations and agreements.
- Ensuring that assigned staff are appropriately prepared to support current and anticipated activities for receipt, processing, distribution/submission of reports from global development programs and globally marketed products.
- Ensuring inspection readiness; monitoring quality of PV deliverables; and monitoring compliance with case submission timelines as per regulatory requirements and agreements with License Partners and other parties.
- May have a central role in audits and health authority inspections.
- Primary accountability for ICSR quality standards, CAPA ownership, KPI governance, and metrics-driven operational oversight across all case processing activities.
Discover your role:
- Responsible for accurate and timely case processing deliverables across global development programs and marketed products.
- Oversee ICSR quality review processes, including narrative quality, case validity, completeness of assessments, and source document reconciliation.
- Establish and maintain tiered quality review frameworks and quality sampling strategies appropriate to case complexity, risk level, and product lifecycle stage.
- Drive continuous improvement in ICSR quality by identifying trends, root causes of recurring errors, and implementing targeted remediation.
- Assume a supporting role in interactions with auditors and Health Authority inspectors.
- Assume a central role in responding to audit / inspection findings.
- Lead root cause analysis (RCA) for quality deviations, case processing errors, and compliance failures; ensure findings are well-documented and actionable.
- Develop, own, and track Corrective and Preventive Actions (CAPAs) to closure, including scheduling and conducting effectiveness checks post-implementation.
- Ensure CAPA commitments made to health authorities, auditors, or internal quality teams are met within agreed timelines; escalate risks proactively.
- Track and analyze operational metrics including case volumes, processing cycle times, resource utilization, overtime trends, and vendor performance benchmarks.
- Develop and maintain vendor performance metrics frameworks; conduct regular governance meetings to review performance against contractual SLAs.
- Ensure compliance with all regulations, guidelines, guidances and Regeneron SOPs and Working Instructions governing pharmacovigilance.
- Responsible for mentorship and active support of assigned staff.
- Responsible for ensuring deliverables and interests are communicated to senior management, internal partners, and external partners in a timely manner.
- Skillful management and resolution of issues, which may, depending on complexity, require effective escalation.
- Manage workload in meeting compliance objectives, optimizing job performance/ contributions, and achieving high levels of work quality.
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Requirements:
- Minimum Bachelor's Degree, Advanced Degree preferred; with 10 years of Pharmacovigilance/Drug Safety/PV Quality experience.
- Previous Pharmacovigilance/Drug Safety experience in pharmaceutical / biotech industry.
- Well informed on relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
- Experience with managing and supervising teams on complex projects. Demonstrated success in working on cross-functional teams.
- Contributes to and manages organizational projects and goals to support their timely completion.
- Assists group members with their activities, as needed. Generally, accomplishes tasks through Individual Contributors or other managers.
When & where:
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- Work Location: Warren, NJ, Tarrytown, NY or Cambridge, MA
- Schedule: 4 days per week on site
- Travel: 25% may be required
Regeneron Commitment:
- 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
Total Rewards:
Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Background Checks:
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
Salary Range:
$157,200.00 - $256,600.00 annually
Does this sound like you? Apply now to take your first step towards living the Regeneron Way!
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