Senior Manager, Global Pharmacovigilance QA

Senior Manager
- Contract
- Cambridge, MA (REMOTE)

Are you a seasoned Pharmacovigilance Quality professional ready to shape global PV compliance, drive inspection readiness, and strengthen patient safety on an international scale?

Proclinical is seeking a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to join a dynamic team remotely based in Cambridge, MA.

This position reports to the Director of Global PV Quality Assurance and involves regular interaction with cross-functional teams.

The successful candidate will provide quality oversight of global post-marketing pharmacovigilance systems, ensuring compliance with Good Pharmacovigilance Practices (GVP) and other international PV regulations. You will play a key role in supporting the development and execution of GVP audit programs, inspection readiness, and cross-functional collaboration to enhance the global pharmacovigilance system.

• A university degree in life sciences or an equivalent qualification/experience.
• Experience in the pharmaceutical industry, particularly in quality or compliance functions.
• Proficiency in conducting GVP audits is preferred.
• Strong understanding of international GVP regulations, FDA PV requirements, Health Authority guidance, and ICH standards.
• Experience supporting health authority inspections.
• Self-motivated with a focus on continuous improvement and strategic thinking.
• Excellent interpersonal, verbal, and written communication skills, with the ability to build positive and productive relationships.
• Professionalism in handling sensitive and confidential information.
• Strong analytical skills to evaluate complex situations and propose effective solutions.

• Collaborate with internal teams to enhance the global pharmacovigilance system and ensure compliance with GVP regulations, including reviewing procedural documents.
• Support non-interventional, observational, and post-marketing surveillance (PMS) studies to meet regulatory requirements, considering Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP).
• Contribute to cross-GxP QA activities requiring PV and PMS expertise.
• Execute global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other service providers in a post-marketing environment.
• Evaluate and investigate quality events, assess root cause analyses, and determine corrective and preventive actions (CAPAs) using risk-based approaches.
• Communicate and escrow critical matters to management effectively.
• Support the Global Strategic Audit Program, including risk-based audit strategy development, maintenance of PV audit tools, and lifecycle management of the PV audit schedule.
• Conduct audits (remote and in-person), prepare audit reports, and manage CAPA implementation.
• Provide QA audit, CAPA, and supplier data for the PV System Master File (PSMF) and maintain efficient processes for accurate data management.
• Oversee PV and PMS-related vendors, including vendor qualification assessments, quality agreements, key quality indicators (KQIs), and audits.
• Develop and report GVP QA metrics and dashboards to support quality oversight.
• Create and deliver GVP QA training plans and conduct training sessions for internal teams.
• Lead or contribute to quality or PV/PMS initiatives, identifying and implementing process improvement opportunities.
• Support inspection readiness and management activities related to PV and PMS.