PV Case Operations Lead — Quality & Compliance

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

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.