Senior PV Case Operations Leader – Quality & Compliance

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

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.