Global Pharmacovigilance Policy, Regulation and Compliance Manager

Job summary

The Global Pharmacovigilance Policy, Regulation and Compliance Manager supports the Global Pharmacovigilance organization and the Qualified Person for Pharmacovigilance to enhance the global pharmacovigilance system, focusing on compliance, training, audits, and regulatory requirements.

Responsibilities

• Coordinate the preparation and distribution of monthly GPV compliance reports, including data extraction and KPI tracking.
• Maintain oversight of GPV procedures and training activities, including document management and training implementation.
• Manage GPV training curricula and assist supervisors with training plans and compliance documentation.
• Support the nomination process for local pharmacovigilance roles and oversee local PV procedures.
• Coordinate GPV audits and inspections, including planning and documentation preparation.
• Ensure oversight of pharmacovigilance agreements, including creation and monitoring of contractual obligations.
• Assist in the preparation and maintenance of the Pharmacovigilance System Master File.
• Coordinate pharmacovigilance communications with external partners.
• Act as the primary contact for cross-functional stakeholders to ensure compliance with global requirements.

Qualifications

• Degree or diploma in veterinary science, pharmacy, life sciences, or related field preferred, with 2-3 years of experience in a regulated industry.
• Proficient in English.

Skills

• Effective teamwork and compliance orientation.
• Strong personal accountability and execution drive.

Education

• Degree or diploma in a relevant field preferred.