Local Pharmacovigilance Manager & Regulatory Manager

Elanco; United States; On-site; USD 79,000 - 112,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Fluent French

Excellent English

Regulatory knowledge

Pharmacovigilance experience

Communication skills

Education

Pharmaceutical or life-science degree

Veterinary degree

Job description

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:

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.

Your Responsibilities:

• 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.

What You Need to Succeed (minimum qualifications):

• 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.

What will give you a competitive edge (preferred qualifications):

• 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.

Additional Information:

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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