Job Summary

Your role: The GPV PRC Manager supports the Global Pharmacovigilance (GPV) organization and the Qualified Person for Pharmacovigilance (QPPV) to maintain and advance the global PV system concerning procedure, training, audit/inspection, PV agreements/contracts, compliance management related tasks, and regulatory requirements (e.g. Pharmacovigilance System Master File (PSMF)) and communication. The GPV PRC Manager coordinates or performs the activities within the department and is in contact with the described interfaces of other departments. By executing the described tasks, the GPV PRC Manager is continuously challenging the existing processes and defined workflows and is seeking creative, new solutions to improve compliance, efficiency and effectiveness.

Responsibilities

- Coordinate the preparation and distribution of monthly Global Pharmacovigilance (GPV) compliance reports, including data extraction, KPI tracking, trend analysis, and collaboration with cross-functional stakeholders.
- Maintain oversight of GPV procedures and training activities, including procedure lifecycle management, document authoring and review, training implementation, and support for onboarding and offboarding processes.
- Manage GPV training curricula and support supervisors in assigning training plans, curricula, and system modules, while ensuring appropriate documentation and compliance.
- Support the nomination process for local pharmacovigilance roles and maintain oversight of local PV procedures and quality management activities.




- Coordinate and support GPV audits and inspections, including audit planning, preparation of documentation, stakeholder coordination, response management, and CAPA monitoring.
- Ensure oversight of pharmacovigilance agreements (PVAs), including the creation, maintenance, periodic review, and monitoring of contractual PV obligations.
- Support the preparation and maintenance of the Pharmacovigilance System Master File (PSMF), including content development and annex management.
- Coordinate pharmacovigilance-related communications with external partners and customers in accordance with internal procedures and communication plans.
- Act as the primary point of contact for cross-functional stakeholders, including Quality and regional affiliates, to ensure compliance with global pharmacovigilance requirements.

What You Need to Succeed (minimum qualifications)
- Degree or diploma in veterinary science, pharmacy, life sciences, or related is preferred and 2-3 of years experience in regulated industry
- Positive English language skills

What will give you a competitive edge (preferred qualifications)
- Experience in working effectively in teams
- Compliance oriented
- Personal accountability and a strong drive for execution

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Global Pharmacovigilance Policy, Regulation and Compliance Manager (Bengaluru)
🏢 Elanco
📍 Bengaluru