Senior Manager, Global Pharmacovigilance QA

Shape Global Pharmacovigilance Compliance and Patient Safety

Are you a seasoned Pharmacovigilance Quality professional ready to drive inspection readiness and strengthen patient safety on an international scale? Join a dynamic team remotely based in Cambridge, MA, to provide quality oversight of global post-marketing pharmacovigilance systems. This role reports to the Director of Global PV Quality Assurance and involves regular interaction with cross-functional teams to ensure compliance with Good Pharmacovigilance Practices (GVP) and other international regulations.

Primary Responsibilities

• 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 escalate 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.

Skills and Requirements

• 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.