Associate Director, PV Case Operations

BioSpace; New Jersey; On-site; USD 157,000 - 257,000; Full time

Job summary

Regeneron is seeking an Associate Director for the PV Case Operations team to oversee global pharmacovigilance case processing and vendor deliverables. You will ensure readiness for inspections, quality review of ICSR narratives, and CAPA ownership across products.

The role requires leading cross-functional teams, tracking metrics, and maintaining regulatory compliance with FDA/EU/ICH guidelines. Travel and on-site presence are involved as per program needs.

Qualifications

• Minimum Bachelor's Degree, advanced degree preferred; with 10 years of PV/Drug Safety experience.
• Previous PV/Drug Safety experience in pharmaceutical/biotech.
• Well informed on FDA, EU and ICH guidelines governing PV activities for clinical trial and post-marketing.
• Experience leading and supervising teams on complex projects; cross-functional collaboration.

Responsibilities

• Oversee PV operations and case processing deliverables across global programs and marketed products.
• Manage ICSR quality review processes including narrative quality and source document reconciliation.
• Establish tiered quality review frameworks and sampling strategies by case complexity and lifecycle stage.
• Drive quality improvements by identifying trends and root causes; implement remediation.
• Support audits and interactions with Health Authorities; respond to audit findings.
• Develop and track CAPAs and closure, with effectiveness checks post-implementation.
• Monitor KPIs, case volumes, cycle times, and vendor performance against SLAs.
• Ensure compliance with regulations and Regeneron SOPs for PV activities.

Skills

Pharmacovigilance

Quality Assurance

Team Leadership

Regulatory Guidance

Auditing

Education

Bachelor's degree

Advanced degree preferred

Tools

ICSR systems

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.

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; elevate 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.

We are committed to building a workplace with an inclusive culture. 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. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

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
• 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.

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.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$157,200.00 - $256,600.00