France Pharmacovigilance & Regulatory Manager

Elanco; Paris; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Elanco Animal Health is seeking a Local Pharmacovigilance Manager and Regulatory Manager in France to lead local PV activities and maintain regulatory compliance for the portfolio. You will serve as the French affiliate's key PV contact, oversee AE and product complaint reporting, coordinate audits, and collaborate with European and global teams to ensure timely regulatory submissions and MA maintenance.

Fluent French and English, a veterinary degree for PV responsibilities, and strong

Qualifications

• University-level education in a pharmaceutical or life-science discipline.
• Veterinary degree required for pharmacovigilance responsibilities.
• Experience in pharmacovigilance and knowledge of French regulatory affairs.
• Excellent written and verbal communication; fluent French and English.

Responsabilités

• Act as the local point of contact for Pharmacovigilance within the French affiliate.
• Maintain and oversee the local pharmacovigilance system with AE and product complaint reporting.
• Coordinate PV audits and inspections; liaise with EU QPPV and global teams.
• Provide regulatory guidance to the business and interact with Regulatory Authorities.
• Plan regulatory activities for assigned products, including new registrations and MA maintenance.
• Submit variations and regulatory documentation to ensure ongoing compliance.
• Collaborate with cross-functional teams across local, European and global Elanco groups.

Connaissances

Pharmacovigilance

Regulatory affairs

French language

English language

Communication skills

Formation

Pharmaceutical or life-science degree

Veterinary degree

Regulatory knowledge

Description du poste

Elanco Animal Health is seeking a Local Pharmacovigilance Manager and Regulatory Manager in France to lead local PV activities and maintain regulatory compliance for the portfolio. You will serve as the French affiliate's key PV contact, oversee AE and product complaint reporting, coordinate audits, and collaborate with European and global teams to ensure timely regulatory submissions and MA maintenance.

Fluent French and English, a veterinary degree for PV responsibilities, and strong