Remote Senior PV QA Lead for Global Compliance

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

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.