SDEA Safety Coordinator – France

Excelya>All job opportunites>Full-time, Permanent Contract>SDEA Safety Coordinator – 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 in the drafting of Safety Data Exchange Agreements and other contracts with PV clauses;
– Produce reconciliations and periodic activity reports with subsidiaries/partners;
– Calculate metrics (KPIs) for subsidiaries’ and distributors’ pharmacovigilance activities;
– Send out annual pharmacovigilance training to partners and 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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