Senior Manager, Global Pharmacovigilance QA

Proclinical; Cambridge; Remote; GBP 106,000 - 144,000; Full time

Job summary

Proclinical is seeking a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to shape PV compliance and inspection readiness on an international scale. The role is remotely based in Cambridge, MA and reports to the Director of Global PV Quality Assurance.

You will oversee global PV systems, lead GVP audits, and collaborate with cross-functional teams to strengthen patient safety and regulatory compliance across markets.

Qualifications

• University degree in life sciences or equivalent.
• Experience in pharmaceutical quality or compliance functions.
• Proficiency in conducting GVP audits is preferred.
• Strong understanding of international GVP regulations, FDA PV requirements, ICH standards.
• Experience supporting health authority inspections.

Responsibilities

• Provide quality oversight of global post-marketing PV systems, ensuring GVP compliance.
• Support development and execution of GVP audit programs and inspection readiness.
• Collaborate with cross-functional teams to enhance the global PV system.
• Execute audits for licensing partners, vendors, affiliates, and service providers.
• Evaluate quality events, determine CAPAs using risk-based approaches.
• Support PV system Master File data and QA metrics.

Skills

GVP knowledge

Quality assurance

Regulatory inspections

GVP audits

Cross-functional collaboration

Education

Life sciences degree

Tools

QA software

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 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.