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.
To learn more about us, visit www.excelya.com
What we offer:
A Safety Project Leader is the project manager of the Pharmacovigilance (PV) & Safety team, responsible for the implementation/provision of the activities/services described within a project/service agreement. Safety Project Leaders are assuming full ownership of their assigned projects, including budget, contract maintenance (renewals, extensions, scope etc.), project quality and efficiency as well as audit readiness.
The Safety Project Leader assists/participates also to other projects of PV & Safety, where as a team member provides support/expertise to handling of product safety issues (e.g. pharmacovigilance, device or cosmeto-vigilance).
As FR responsible person for pharmacovigilance, ensures Marketing Authorisation Holders (MAH) comply with local pharmacovigilance requirements and is the contact person for the local Health Authority and the MAH’s EU-QPPV.
Product Vigilance Activities:
Team Management and planning:
Client Relationship Management:
Key Skills and Attributes: