Global PV QA Senior Manager - Remote

Proclinical; Cambridge (MA); Remote; USD 150,000 - 190,000; Full time

Job summary

Proclinical seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to lead quality oversight of global PV systems from Cambridge, MA, with remote engagement across international teams.

The role reports to the Director of Global PV Quality Assurance and focuses on GVP compliance, audit programs, inspection readiness, and cross-functional collaboration to strengthen patient safety globally.

Qualifications

• Experience in pharmaceutical industry, quality or compliance functions.
• Experience conducting GVP audits.
• Understanding of international GVP regulations, FDA PV requirements, ICH standards.
• Experience supporting health authority inspections.
• Excellent communication and ability to build relationships.
• Strong analytical skills for evaluating complex situations.
• Professional handling of sensitive information.

Responsibilities

• Collaborate with internal teams to enhance the global pharmacovigilance system and ensure GVP compliance.
• Support observational studies and PMS to meet regulatory requirements.
• Contribute to cross-GxP QA activities requiring PV/PMS expertise.
• Execute global core auditing for licensing partners, external vendors, internal audits, affiliates, and service providers.
• Evaluate quality events, determine CAPAs using risk-based approaches.
• Communicate critical issues to management.
• Develop and maintain PV audit tools and lifecycle management of the PV audit schedule.
• Conduct audits (remote and in-person) and prepare audit reports.

Skills

Analytical thinking

Interpersonal communication

Verbal communication

Written communication

Strategic thinking

Continuous improvement

Self-motivation

Education

Life sciences degree

Job description

Proclinical seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to lead quality oversight of global PV systems from Cambridge, MA, with remote engagement across international teams.

The role reports to the Director of Global PV Quality Assurance and focuses on GVP compliance, audit programs, inspection readiness, and cross-functional collaboration to strengthen patient safety globally.