France Pharmacovigilance & Regulatory Manager

Elanco; United States; Sur place; USD 79 000 - 112 000; Plein temps

Résumé du poste

Elanco is seeking a Local Pharmacovigilance Manager and Regulatory Manager to act as the France affiliate's PV lead and ensure regulatory compliance of the portfolio. You will manage the local PV system, oversee AE and PC reporting, and coordinate interactions with Regulators and cross-functional teams.

In this dual role, you will drive regulatory activities for existing Marketing Authorizations and new registrations, while maintaining inspection readiness and collaborating with EU, global PV

Qualifications

• University-level degree in pharma or life sciences; veterinary degree preferred for PV responsibilities.
• Experience in Pharmacovigilance activities.
• Knowledge of French Regulatory Affairs legislation.
• Fluent French with strong English communication.
• Ability to collaborate with cross-functional and international teams.

Responsabilités

• Act as local point of contact for PV within the French affiliate.
• Maintain local PV system and manage AE and PC reporting.
• Coordinate PV audits and inspections; liaise with EU QPPV and Global PV.
• Provide regulatory guidance and manage MA maintenance and new registrations.
• Ensure timely regulatory submissions and documentation.

Connaissances

Fluent French

Excellent English

Regulatory knowledge

Pharmacovigilance experience

Communication skills

Formation

Pharmaceutical or life-science degree

Veterinary degree

Description du poste

Elanco is seeking a Local Pharmacovigilance Manager and Regulatory Manager to act as the France affiliate's PV lead and ensure regulatory compliance of the portfolio. You will manage the local PV system, oversee AE and PC reporting, and coordinate interactions with Regulators and cross-functional teams.

In this dual role, you will drive regulatory activities for existing Marketing Authorizations and new registrations, while maintaining inspection readiness and collaborating with EU, global PV