Global Pharmacovigilance Policy, Regulation and Compliance Manager (Fixed duration - 2 years)
Elanco
August 20, 2026
Remote friendly (Milano, TX)
United States
Corporate Functions
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, including procedures, training, audit/inspection activities, PV agreements/contracts, compliance management tasks, regulatory requirements (e.g., Pharmacovigilance System Master File (PSMF)), and communication. Fixed duration: 2 years.
Your responsibilities:
- Coordinate preparation and distribution of monthly GPV compliance reports (data extraction, KPI tracking, trend analysis) with cross-functional stakeholders.
- Maintain oversight of GPV procedures and training (procedure lifecycle management, document authoring/review, training implementation; support onboarding/offboarding).
- Manage GPV training curricula and support supervisors with training plans/curricula/system modules and documentation/compliance.
- Support nomination process for local pharmacovigilance roles; oversee local PV procedures and quality management activities.
- Coordinate/support GPV audits and inspections (planning, documentation, stakeholder coordination, response management, CAPA monitoring).
- Oversee pharmacovigilance agreements (PVAs): creation, maintenance, periodic review, and monitoring of contractual obligations.
- Support preparation/maintenance of the PSMF (content development and annex management).
- Coordinate pharmacovigilance communications with external partners/customers per internal procedures and plans.
- Primary point of contact for cross-functional stakeholders (including Quality and regional affiliates) for global PV compliance.
Minimum qualifications:
- Degree/diploma in veterinary science, pharmacy, life sciences, or related (preferred) and 2–3 years’ experience in a regulated industry.
- Good English language skills.
Preferred qualifications:
- Experience working effectively in teams.
- Compliance oriented.
- Personal accountability and strong drive for execution.
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, including procedures, training, audit/inspection activities, PV agreements/contracts, compliance management tasks, regulatory requirements (e.g., Pharmacovigilance System Master File (PSMF)), and communication. Fixed duration: 2 years.
Your responsibilities:
- Coordinate preparation and distribution of monthly GPV compliance reports (data extraction, KPI tracking, trend analysis) with cross-functional stakeholders.
- Maintain oversight of GPV procedures and training (procedure lifecycle management, document authoring/review, training implementation; support onboarding/offboarding).
- Manage GPV training curricula and support supervisors with training plans/curricula/system modules and documentation/compliance.
- Support nomination process for local pharmacovigilance roles; oversee local PV procedures and quality management activities.
- Coordinate/support GPV audits and inspections (planning, documentation, stakeholder coordination, response management, CAPA monitoring).
- Oversee pharmacovigilance agreements (PVAs): creation, maintenance, periodic review, and monitoring of contractual obligations.
- Support preparation/maintenance of the PSMF (content development and annex management).
- Coordinate pharmacovigilance communications with external partners/customers per internal procedures and plans.
- Primary point of contact for cross-functional stakeholders (including Quality and regional affiliates) for global PV compliance.
Minimum qualifications:
- Degree/diploma in veterinary science, pharmacy, life sciences, or related (preferred) and 2–3 years’ experience in a regulated industry.
- Good English language skills.
Preferred qualifications:
- Experience working effectively in teams.
- Compliance oriented.
- Personal accountability and strong drive for execution.