Safety Sdea Expert

il y a 21 heures

Paris, France Excelya Temps plein

HybridOperations, PV & SafetyFull time
Paris, Île-de-France, France
OVERVIEW
Description
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.
Participate in the weekly quality control of case processing activities (data entry, coding, narrative writing) performed by the platforms, including medical review of cases:
Generate and review listings, verify data against source documents, and ensure overall data consistency.
Share listings with corrections and clarification requests via the platforms’ SharePoint.
Follow up on platforms’ responses and ensure that corrections or clarifications are properly implemented.
Validate and sign off on quality control reviews.
Perform quality checks on narratives of clinical study cases provided by the platforms for inclusion in Clinical Study Reports (CSR).
Support the supervision of pharmacovigilance case reconciliation with partners (Safety Data Exchange Agreements - SDEA) and alignment of safety cases with the clinical database outsourced to platforms.
Conduct medical review and validation of oncology cases.
**Requirements**:
About You
At 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**: Solid knowledge of pharmacovigilance processes and international regulations (e.g., GVP, ICH). Experience in case processing, medical review, and narrative quality control, ideally in a CRO or pharmaceutical environment.
**Education**: Minimum Master’s degree (Bac +5) in Pharmacovigilance or a related field
**Languages**: Fluency in French & 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.

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