Pharmacovigilance Medical Expert – France (Lyon)

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique—

We 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 Job

Join 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 Safety. 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 Responsibilities

• Act as a pharmacovigilance (PV) expert and primary contact for clinical sites and project teams.

• Validate and assess adverse events entered in the pharmacovigilance database.

• Perform and validate coding of safety data using MedDRA and drug treatments using WHODrug.

• Contribute to safety signal management and the handling of safety alerts.

• Manage and present safety data to Clinical Trial Safety Monitoring Committees (DSMCs).

• Draft safety-related sections of clinical trial documentation (e.g., protocols, patient information sheets).

• Assess updates to reference safety documents and their impact on ongoing trials.

• Participate in the validation and maintenance of the pharmacovigilance database in a validated state.

• Collaborate with internal departments (Monitoring, Data Management, Biostatistics, Project Management).

• Provide pharmacovigilance training across departments and to new employees.

• Participate in or lead transversal projects to improve PV tools, processes, and procedures.

• Ensure compliance with internal quality procedures and regulatory requirements (ICH, GCP, etc.).