Senior Global Pharmacovigilance Policy and Compliance Manager (EU)

Job summary

The Senior Global Pharmacovigilance (PV) Policy, Regulation and Compliance Manager serves as the deputy Qualified Person for Pharmacovigilance (QPPV) in the EU, supporting the Global Pharmacovigilance organization. This role focuses on maintaining and enhancing the global PV system, ensuring compliance with regulatory requirements, and coordinating various compliance-related activities.

Qualifications

• Degree in Veterinary Medicine
• Minimum of 3 years of experience in a regulated industry, preferably in pharmacovigilance
• Knowledge of Veterinary Pharmacovigilance processes and regulatory requirements in the EU
• Proficient in English

Responsibilities

• Oversee GPV procedures, training programs, and onboarding/offboarding processes
• Manage the lifecycle of Pharmacovigilance Agreements (PVAs) and ensure compliance
• Coordinate compliance reporting, metrics, and communication with stakeholders
• Support GPV audits, inspections, and maintenance of the Pharmacovigilance System Master File (PSMF)
• Act as a liaison between GPV, Quality, and external partners
• Deputize for the EU/UK QPPV as needed, including interactions with regulatory authorities
• Provide strategic guidance on PV and support benefit-risk monitoring
• Drive continuous improvement and compliance initiatives within Global Pharmacovigilance

Skills

• Strong decision-making capabilities and ability to work independently
• Compliance-oriented with a quality-focused mindset
• Experience in managing complex compliance projects
• Familiarity with interactions with EU competent authorities
• Team player with experience in multicultural environments

Education

• Degree in Veterinary Medicine

Tools

• Familiarity with compliance management systems and regulatory documentation