Global Pharmacovigilance Policy, Regulation and Compliance Manager (Fixed duration - 2 years)

At Elanco (NYSE: ELAN), we are a global leader in animal health dedicated to innovation and delivering products and services that prevent and treat disease in farm animals and pets. Our vision, Food and Companionship Enriching Life, and our purpose—Go Beyond for Animals, Customers, Society and Our People—drive us. We foster a diverse and inclusive work environment where innovation, creativity, and business success thrive.

About the role

The GPV PRC Manager supports the Global Pharmacovigilance (GPV) organization and the Qualified Person for Pharmacovigilance (QPPV) in maintaining and advancing the global PV system. This includes procedure management, training, audit/inspection coordination, PV agreements/contracts, compliance tasks, and regulatory requirements (e.g., Pharmacovigilance System Master File (PSMF)) and communication. The role involves coordinating activities within the department and interfacing with other departments to improve compliance, efficiency, and effectiveness. This is a fixed-duration role for 2 years.

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.

Qualifications

• Minimum qualifications:
  • Degree or diploma in veterinary science, pharmacy, life sciences, or a related field (preferred).
  • 2-3 years of experience in a regulated industry.
  • Good English language skills.
• Preferred qualifications:
  • Experience working effectively in teams.
  • Compliance-oriented mindset.
  • Personal accountability and a strong drive for execution.

Elanco is dedicated to building a diverse and inclusive work environment. If you think you might be a good fit but don’t meet every qualification, we encourage you to apply.