Senior Manager, Global Pharmacovigilance (PV) Quality Assurance

About the role

Take the lead in shaping global pharmacovigilance quality excellence, overseeing critical audit programmes, vendor quality, and regulatory compliance activities. R&D Partners is seeking a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to provide quality oversight of global post-marketing PV systems. This role focuses on auditing, QA operations, and supporting GVP compliance activities.

Responsibilities

• Provide quality oversight of the company's global post-marketing PV system.
• Develop and execute the global GVP audit program.
• Conduct audits of licensing partners, vendors, affiliates, internal teams, and service providers.
• Evaluate quality events, deviations, root cause analyses, and CAPAs.
• Support risk-based audit strategies and maintain the PV audit universe and schedule.
• Provide audit, CAPA, and supplier data for the Pharmacovigilance System Master File (PSMF).
• Develop and maintain audit processes, tools, and quality metrics.
• Support PV/PMS inspection readiness and inspection management.
• Oversee PV/PMS vendors, including quality agreements, KQIs, vendor qualification, and audits.
• Support GVP QA training and process improvement initiatives.

Requirements

Must have legal authorization to work in the United States.

• Must-Have: 10+ years of experience in PV Quality Assurance, with strong GVP auditing and QA operations expertise.
• Proven experience leading audits (not just supporting them).
• Strong understanding of PV regulations and GVP requirements.
• Experience with deviation management, CAPAs, quality events, change controls, and QMS lifecycle.
• Familiarity with the Pharmacovigilance System Master File (PSMF).
• Pharmaceutical industry experience in a quality/QA function.
• Bachelor's degree (minimum).

Nice-to-Have (Preferred):

• Advanced degree (Master's, PharmD, or PhD in Pharmacy).
• Experience with digital QMS tools like Veeva Quality Vault.
• Familiarity with PV/PMS vendors, licensing partners, and global GVP regulations.
• Experience supporting Health Authority inspections.

Ideal Candidate Profile

We are looking for a seasoned PV professional with a strong focus on quality and auditing rather than compliance. The candidate should be self-motivated, proactive, and comfortable handling complex quality issues. Strong communication and cross-functional collaboration skills are essential.

Schedule

Work Hours: Must be able to work East Coast hours.

Travel: Occasional travel required for audits.