Senior PV Case Operations Lead

Jobtailor; Massachusetts; On-site; USD 140,000 - 210,000; Full time

Job summary

Jobtailor is seeking a Senior Pharmacovigilance Quality Leader to oversee global PV operations, case processing standards, and vendor management. You will drive inspection readiness and ensure high-quality ICSR deliverables across development programs and marketed products.

You will mentor teams, implement CAPA strategies, and partner with internal and external stakeholders to sustain regulatory compliance with FDA, EU, and ICH guidelines.

Qualifications

• Minimum Bachelor’s Degree; advanced degree preferred.
• 10 years of Pharmacovigilance/Drug Safety/Quality experience.
• Previous Pharmacovigilance/Drug Safety in pharma/biotech industry.
• Knowledge of FDA, EU and ICH guidelines governing pharmacovigilance.

Responsibilities

• Oversee pharmacovigilance operations and case processing deliverables.
• Ensure inspection readiness and regulatory compliance across programs.
• Lead CAPA development and tracking through closure with effectiveness checks.
• Mentor staff and manage vendor performance; communicate with stakeholders.
• Support audits/inspections and respond to findings.

Skills

Pharmacovigilance Oversight

ICSR Quality Management

Regulatory Compliance

Team Leadership

CAPA Development

Vendor Management

Audit Support

Cross-functional Collaboration

Education

Bachelor’s Degree

Advanced degree preferred

Job description

Jobtailor is seeking a Senior Pharmacovigilance Quality Leader to oversee global PV operations, case processing standards, and vendor management. You will drive inspection readiness and ensure high-quality ICSR deliverables across development programs and marketed products.

You will mentor teams, implement CAPA strategies, and partner with internal and external stakeholders to sustain regulatory compliance with FDA, EU, and ICH guidelines.