Vigilance Agreement Manager – France

Excelya>All job opportunites>Full-time, Permanent Contract>Vigilance Agreement Manager – France

Job description

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

What we offer:

  • Participate to the scientific and international regulatory intelligence.
  • Provides expertise and support to analyse the impact of new scientific or regulatory information.
  • Update the quality documentation on their perimeter.
  • Check the compliance to quality reference documents on their perimeter.
  • Participate to the preparation and conduct of vigilance audits and inspections as well as to the implementation of corrective and preventive actions.
  • Elaborate or contribute to the elaboration of training materials related to their field of activity.
  • Inform their manager of any emerging issue or any information which may influence the security of the medicinal products or may need to be reported to health authorities.
  • Cooperate with other colleagues to ensure the business continuity in vigilance
  • Set up, negotiate until the signature of the Vigilance Agreements (SDEA and MDVA) 
  • Amend the Vigilance Agreements as per the applicable procedure.
  • Implement vigilance clauses with the company partners.
  • File and track in the dedicated folders and databases the vigilance agreements/ amendments and related information.
  • Maintain up to date the tracker of the vigilance contact persons at local level and share every update with the dedicated teams.
  • Provide regular indicators on the status of signature of the Vigilance Agreements.
  • Contribute to the updates of the PSMF.

Minimum Requirements :

  • Scientific background, ideally pharmacist.
  • 4-6 years of experience in the corporate vigilance department of a pharmaceutical company is mandatory.
  • Solid knowledge of the management of vigilance agreements is mandatory.
  • A previous experience in quality assurance, audit or compliance activities would be a plus.
  • Professional English (written and spoken) is required



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