Senior Manager, Global Pharmacovigilance QA

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

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.

Primary Responsibilities:

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.

Skills & 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.

The Senior Manager's responsibilities will be:

• 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 elevate 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.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at [e-mail].