Safety Database Officer

Excelya Group; Saclay; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

A leading mid-size CRO in Île-de-France seeks a Pharmacovigilance Specialist for a contract role of 6-9 months. The position involves database administration, monitoring E2B exchanges, and reporting requirements. Ideal candidates will have at least 3 years of experience, proficiency in pharmacovigilance databases, and fluency in English. This opportunity allows for engagement in diverse projects within a committed healthcare community focused on improving the patient journey.

Qualifications

• Minimum 3 years in Pharmacovigilance.
• Proficient in pharmacovigilance database.
• Fluency in English is required.

Responsabilités

• Respond to requests regarding database configuration.
• Monitor E2B data exchanges and assist in incident resolution.
• Gather requirements for new Business Objects reports.

Connaissances

Pharmacovigilance

Database administration

Monitoring anomalies

Requirement gathering

Incident resolution

Formation

Degree in Life Sciences

Outils

Pharmacovigilance database

Description du poste

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.

About You

We are looking for candidates who embody our values of Audacity, Care, and Energy:

• Experience: Minimum 3 years in Pharmacovigilance
• Tools: Proficient in pharmacovigilance database
• Education: Degree in Life Sciences
• Languages: Fluency in English is required