description du poste

Why Join Us?At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.Here’s what makes us uniqueWe are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.About the JobJoin Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.Main ResponsibilitiesObjectives: Supervision of pharmacovigilance (PV) case management outsourced to two service providers.General Description of ResponsibilitiesThe consultant will oversee pharmacovigilance case management, including:Supervision of Outsourced Case ProcessingResponding to emails from service providers regarding case management.Monitoring case processing timelines and identifying reasons for delays in case reporting/transmission.Weekly Quality Control (QC) of Case ProcessingGenerating listings and verifying data consistency against source documents.Uploading corrected listings or clarification requests to the service providers’ SharePoint.Reviewing service providers’ responses to corrections/clarifications.Approving QC by signing off.Additional ResponsibilitiesParticipation in QC of clinical study narratives (provided by service providers) for inclusion in clinical study reports.Supervision of PV case reconciliation with partners (SDEA) and outsourced clinical databases.Medical review of oncology cases.About YouAt Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.Experience: Proven ability to thrive in collaborative, fast-moving environments (avoid requiring minimum years—talent matters most to us)Skills: Experience with contract drafting, SDEAs, and oversight of third-party vendors, Strong background in international pharmacovigilance project coordination.Education: Degree in Life Sciences, Pharmacy, or Project ManagementLanguages: Fluency in French English