Associate Director, PV Case Operations

Regeneron Pharmaceuticals•Warren, MI

3d•Hybrid

About The Position

Regeneron is seeking an Associate Director to join our PV Case Operations team. This role is 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. The Associate Director ensures 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. This role is also responsible for ensuring inspection readiness, monitoring the quality of PV deliverables, and monitoring compliance with case submission timelines as per regulatory requirements and agreements with License Partners and other parties. The incumbent may have a central role in audits and health authority inspections. This position 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.

Requirements

Minimum Bachelors Degree, Advanced Degree preferred
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.

Responsibilities

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.