PV Case Operations: Associate Director, ICSR Quality

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

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.