Local Pharmacovigilance Manager & Regulatory Manager

• University-level education in a pharmaceutical or life-science discipline, such as veterinary medicine/pharmacy, or a comparable qualification supported by relevant professional experience.
• Veterinary degree required for the Pharmacovigilance responsibilities.
• Experience in Pharmacovigilance activities
• Knowledge of French Regulatory Affairs legislation.
• Excellent written and verbal communication skills.
• Fluent French and excellent written and spoken English.

• Experience working effectively across different functions and within an international environment.
• Strong personal accountability and ability to independently drive activities to completion.
• Excellent attention to detail and a strong analytical mindset.
• Proactive approach to identifying opportunities for process, compliance and efficiency improvements.

In this combined Pharmacovigilance (PV) and Regulatory Affairs (RA) role, you will act as the local representative of the Elanco Pharmacovigilance organization in France while ensuring the regulatory compliance of our product portfolio.

As Local Pharmacovigilance Manager (LPVM), you will lead local pharmacovigilance activities, maintain the local PV system and ensure compliance with French regulatory and Elanco requirements.

As Regulatory Manager (RAM), you will manage regulatory activities for assigned products, maintain existing Marketing Authorizations and contribute to new registrations in France.

• →Act as the key local point of contact and provide leadership for all Pharmacovigilance matters within the French affiliate.
• →Maintain and oversee the local pharmacovigilance system, ensuring compliant management and reporting of Adverse Events (AEs) and Product Complaints (PCs).
• →Manage PV-related communication with Regulatory Authorities and ensure appropriate training, documentation and ongoing compliance with local and Elanco requirements.
• →Coordinate PV audits and inspections, maintain inspection readiness and work closely with the EU QPPV, Global PV and Quality teams on product safety and risk management activities.
• →Manage relationships and interactions with relevant Regulatory Authorities and provide regulatory guidance to the business.
• →Plan and coordinate regulatory activities for assigned products, including new registrations and maintenance of existing Marketing Authorizations (MAs).
• →Ensure ongoing regulatory compliance through timely submission of variations, change controls and other required regulatory documentation, including compliance of product information and promotional materials.
• →Partner with local, European and global cross-functional teams and proactively identify opportunities to improve product safety, regulatory compliance and operational efficiency.

This position combines key responsibilities across Pharmacovigilance and Regulatory Affairs in France and requires close collaboration with local, European and global Elanco teams, Regulatory Authorities and external partners.

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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