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:
Within the Pharmaceutical and Medical Affairs Department, and more specifically the Group Vigilances Department, we are recruiting a Pharmacovigilance Data Administrator & Compliance Officer
Your responsibilities:
– Participate in the coordination/animation of subsidiaries and partners, and in monitoring the activities of pharmacovigilance service providers.
– Contribute to the Quality System set up for PV
– Act as administrator of the Pharmacovigilance database and the Literature database
– Be the reference for essential documents on the PV Master File, KPIs and Group documents for monitoring compliance
– Carry out quality controls on PV cases or other PV data in order to verify compliance and maintain or improve quality.
– Participate in the activities of the compliance department (register of incoming cases, reconciliation with partners, preparation of data required for summaries and periodic pharmacovigilance reports).
– Take an active part in audits and inspections as required.
Minimum Requirements :
– Minimum 3 years’ higher education in Pharmacovigilance database management
– Experience in PV case management would be a plus
– Knowledge of MedDRA® dictionary
– Knowledge of the SafetyEasy database or another Pharmacovigilance database
– Basic computer skills (Word, Excel, Powerpoint)
– A first professional experience of 3 or 4 years would be a plus,
– Your rigor and team spirit will enable you to get the most out of this position.
– You speak English
The position is located in Paris Area
