About this role
Role Overview
- Ensure quality review of safety data received from partners before entry into the safety database (completeness, accuracy, compliance).
- Oversee serious adverse event (SAE) management, including coordination and review of case narratives.
- Perform quality checks of aggregate reports (e.g., DSURs).
- Support PV setup for clinical studies and implementation of safety processes.
- Manage PV documentation in eTMF to ensure inspection readiness.
- Contribute to the setup of post-marketing PV systems.
- Collaborate with internal teams and partners to ensure efficient and compliant safety operations.
Requirements
- Degree in Life Sciences, Pharmacy, or related field.
- Solid experience in pharmacovigilance, including case processing and safety data review.
- Good knowledge of PV regulations (GVP, ICH) and clinical trial safety.
- Experience in quality control of safety data and exposure to safety databases/eTMF.
- Strong organizational and stakeholder coordination skills.
- Detail-oriented, proactive, and quality-driven mindset.
- Fluent in English.
Benefits
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.