Associate Director, PV Case Operations

Regeneron; Kentucky; On-site; USD 130,000 - 180,000; Full time

Job summary

Regeneron is seeking an Associate Director to lead PV Case Operations, overseeing ICSR processing and quality across global programs. The role ensures readiness for inspections, drives continuous quality improvements, and maintains robust CAPA and KPI governance.

Collaboration with auditors and health authorities is expected. Located in Warren, NJ; Tarrytown, NY or Cambridge, MA with 4 days on site and up to 25% travel.

Qualifications

• Minimum Bachelor's Degree; Advanced Degree preferred.
• 10 years of Pharmacovigilance/Drug Safety/PV Quality experience.
• Familiar with FDA, EU and ICH PV guidelines and regulations.
• Experience supervising teams on complex projects and cross-functional work.

Responsibilities

• Oversee PV operations and ICSR processing across programs.
• Implement QA processes, quality review and source reconciliation.
• Develop tiered quality review frameworks and sampling strategies.
• Lead CAPA development, closure, and effectiveness checks.
• Interact with auditors and Health Authority inspectors during inspections.
• Monitor KPIs, vendor performance, and regulatory compliance.
• Provide mentorship and senior communication to stakeholders.

Skills

PV quality oversight

Team mentorship

Root cause analysis

KPI governance

Vendor performance

Education

Bachelor's degree

Advanced degree

Job description

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.

Responsible for providing oversight of pharmacovigilance (PV) operations in the successful management of vendor and case processing deliverables in accordance with applicable regulations and agreements. Responsible for 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. Responsible for 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. Incumbent may have a central role in audits and health authority inspections. This role has primary accountability for ICSR quality standards, CAPA ownership, KPI governance, and metrics-driven operational oversight across all case processing activities.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Work Location: Warren, NJ, Tarrytown, NY or Cambridge, MA

4 days per week on site

25% Travel may be required

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; escalation 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.

This role requires:

• Minimum Bachelors 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.
• Assist group members with their activities, as needed. Generally, accomplishes tasks through Individual Contributors or other managers.

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,