Associate Director, PV Case Operations

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

Job summary

Regeneron seeks an Associate Director to lead Pharmacovigilance Case Operations, directing global case processing and ICSR quality across development programs and marketed products. The role emphasizes CAPA ownership, audits, and timely regulatory submissions, with site-based work in Warren, NJ and occasional travel.

You will mentor staff, manage vendor performance, and ensure regulatory compliance while driving continuous quality improvements in a fast-growing, science-driven organization.

Qualifications

• Minimum Bachelor's degree; advanced degree preferred.
• 10 years of Pharmacovigilance/Drug Safety/PV Quality experience.
• Well informed on FDA, EU and ICH guidelines and regulations governing PV activities.
• Experience managing and supervising teams on complex projects.

Responsibilities

• Oversee PV operations for global development programs and marketed products.
• Lead ICSR quality review processes and source document reconciliation.
• Establish tiered quality review frameworks and sampling strategies.
• Drive continuous improvement in ICSR quality and CAPA ownership.
• Interact with auditors and Health Authority inspectors as needed.
• Lead root cause analysis for quality deviations and compliance failures.
• Develop and track CAPAs and ensure timely closure.
• Monitor operational metrics and vendor performance against SLAs.
• Ensure compliance with Regeneron SOPs and regulatory requirements.

Skills

Pharmacovigilance leadership

Team supervision

Regulatory knowledge FDA/EU/ICH

Quality assurance

KPI governance

Vendor management

Education

Bachelor's degree

Advanced degree preferred

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; escal ...
• 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.

Salary Range (annually)

$157,200.00 - $256,600.00

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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. 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.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

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.