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Elanco

Global animal health pharmaceutical company

Local Pharmacovigilance Manager & Regulatory Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeParis, FranceNo salary listedIn-person

About the Job

Requirements

  • University-level education in a pharmaceutical or life-science discipline, such as veterinary medicine or pharmacy, or a comparable qualification supported by relevant professional experience.
  • A veterinary degree is required for the pharmacovigilance responsibilities.
  • Experience in pharmacovigilance activities.
  • Knowledge of French regulatory affairs legislation.
  • Fluency in French and excellent written and spoken English.

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 and product complaints.
  • Manage pharmacovigilance-related communication with regulatory authorities and ensure appropriate training, documentation and ongoing compliance with local and Elanco requirements.
  • Coordinate pharmacovigilance audits and inspections, maintain inspection readiness, and work closely with the EU Qualified Person Responsible for Pharmacovigilance, Global Pharmacovigilance 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.
  • 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.

Desired 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.
  • A proactive approach to identifying opportunities for process, compliance and efficiency improvements.

About the Company

Elanco

Global animal health pharmaceutical company

Elanco is a global animal health company that develops and sells medicines, vaccines, and preventive care products for livestock and pets. Its portfolio includes prescription medicines, vaccines, parasite controls, and other welfare products used by veterinarians, farmers, and pet owners to prevent or treat disease and improve wellbeing. Since becoming independent after separating from Eli Lilly and acquiring Bayer Animal Health in 2020, it ranks as the world’s second-largest animal health company with a broad, globally distributed product line and direct-to-consumer capabilities. Its goal is to improve animal health and welfare worldwide by providing effective, accessible products and services while growing sustainably.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Indianapolis, IN
Founded
1954

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