Global Pharmacovigilance Policy, Regulation and Compliance Manager

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.

We believe that diversity is the driving force behind innovation, creativity, and overall business success.

Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

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.

Your 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 a...