Pharmacovigilance Governance Officer – France

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:

• Support in the execution of activities such as handling of local products, PBER reporting.
• Quality System: Deviations (be comfortable with Sanofi tool – QualiPS0); Quality Document updates.
• Vendor oversight managing AEGIS tool.
• Case Management, HA submissions. 
• aRMM distribution including CFT meetings (cross-functional team meetings)., Follow-up with Medical & Commercial.
• Draft of aRMM in accordance with local labelling.
• PSPV training (sending out of training notifications; PSPV training to Personnel  and Phone calls follow-up.
• Will report to Country Safety Head.