Pharmacovigilance Specialist

The purpose of this function is to support the Case Processing Lead in case processing management and oversight of PV vendor(s) for RRD products.

This role, based in our offices in Puteaux (92), is offered on a fixed-term basis as maternity leave cover, approximately from February to September 2026. 

The Case Processing Officer plays a significant role within Global Pharmacovigilance by contributing to the robustness and compliance of processes linked to the management of vigilance cases in accordance with all requirements: internal, affiliates, Authorities, Partners.
The Case Processing Officer also ensures the monitoring of the service provider(s) in the scope of case processing activities for RRD products, in close collaboration with the Case Processing Lead, Safety monitoring group, DataBase Associates, Compliance teamand Clinical safety group.

Expert in Case Processing: Ensure that all Adverse Event reports (global, clinical, affiliates) are duly processed and submitted / distributed in accordance with regulations/SDEA. Expertise in data entry and medical review.

Vendor Management: Monitor vendor performance on timelines and quality, conduct QC checks, and maintain strong communication channels.

Process Oversight & Improvement: Drive continuous enhancement of case processing workflows and tools, optimizing efficiency, quality, and risk management.

Cross-Functional Collaboration: Represent the Case Processing group in internal and external meetings, ensuring alignment with PV systems, clinical, regulatory, and medical teams.

Compliance & Audits: Support audits and inspections, prepare CAPA plans. Ensure adherence to quality standards and documentation. 

Quality: Contribute to the creation/maintenance of quality documents describing case processing activities, project-related documents and deliverables.

Training & Integration: Contribute to onboarding and professional development of new team members.

Reporting & Governance: Provide regular activity reports, escalate issues, and maintain traceability and completeness of processed data.

Scientific background (MSc or PharmD)

Minimum experience: 4 years of relevant employment in industry, CRO or authority or equivalent experience Funded experience in Pharmacovigilance and/or drug safety
Funded experience in GVP/ICH guidelines

Theoretical and practical knowledge for the performance of Pharmacovigilance activities

Computing: MS Office, safety database

Excellent communication and willingness to work in team
Good knowledge of spoken and written in English, including terminology

Languages: English

Very occasional, limited to one or two meetings in Italy.