Safety Officer – France

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

• Evaluate the safety data from clinical studies on gene or cell therapy, drug repurposing, and companion diagnostics (CDx);
• Draft or oversee the drafting of narratives, summaries, assessments, and pharmacovigilance reports (particularly in collaboration with PV CROs);
• Ensure compliance with regulatory requirements, especially regarding deadlines for case reporting and annual reports;
• Write and validate the pharmacovigilance section of clinical study protocols and regulatory documents (e.g., ANSM, EMA, FDA briefing books);
• Write and validate the pharmacovigilance section of investigator brochures, study reports (CSR), DSUR/PSUR, and marketing authorization (MA) dossiers;
• Provide training and regulatory/quality support (GCP, ICH) to different teams regarding pharmacovigilance aspects;
• Manage collaborations with pharmacovigilance CROs, as well as industrial and academic partners (contracts, budget, audits).