Safety Base Officer H/F - 75

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

Main activities :

- Functional Database Administration: Respond to requests from other Global Safety teams or local teams regarding database configuration. Specifically, create/update studies, products, and submission rules for expedited reporting.
- Participate in the implementation of new E2B data exchanges with authorities and partners, monitor existing E2B exchanges, and assist in incident resolution.
- Participate in maintaining the database in operational condition (monitoring anomalies and updates).
- Participate in gathering requirements for new Business Objects reports (the reporting tool associated with the pharmacovigilance database) or in their development and validation/verification.
- At the request of management, contribute to any other pharmacovigilance-related tasks within the scope of their responsibilities.
- The anticipated duration of the two assignments is 6 and 9 months (January to June 2025 and January to September 2025, respectively). The assignment is renewable if necessary.