Associate Director, PV Case Operations

Regeneron Pharmaceuticals, Inc (USA); Kentucky; On-site; USD 157,000 - 257,000; Full time

Benefits offered by this job

Annual bonuses (incentive plans)

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, V

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc (USA) seeks an Associate Director to lead PV Case Operations, overseeing global case processing and ICSR quality with an emphasis on regulatory compliance and continuous improvement. Location options include on-site work with potential travel.

The role requires a minimum of a Bachelor's degree with 10 years in pharmacovigilance/drug safety, and experience managing teams in a pharma/biotech setting. Strong knowledge of FDA/EU/ICH PV guidelines is essential.

Qualifications

• 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.
• Knowledge of FDA, EU and ICH PV guidelines for clinical trials and post-marketing.
• Experience with managing and supervising teams on complex projects.
• Demonstrated success in working on cross-functional teams.
• Experience guiding cross-functional projects to timely completion.
• Assist group members with their activities, as needed.
• Ability to work through ICs 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 central role in audits and Health Authority inspectors.
• 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.
• 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 require effective escalation.
• Manage workload in meeting compliance objectives, optimizing job performance/ contributions, and achieving high levels of work quality.

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; 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.

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
• 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.

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 (annually) $157,200.00 - $256,600.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.