Customer/project Understanding

Context & challenge

The service started in October 2016 and has been strengthened over the years. A major French Pharmaceutical company has entrusted with several activities, namely the management of part of the spontaneous cases, literature review and case management, Eudravigilance monitoring and processing of part of EV cases as well as SDEA reconciliations.

Currently, the company portfolio includes 1271 products marketed in France and 265 products marketed in 14 countries outside France.

Current scope

  • Spontaneous and literature case management
  • Identification and management of EV cases
    (EVWEB and MLM)
  • Global and local literature (300 DCI / 2 databases and 15 FR local journals
  • Reconciliations

Customer benefits

On-Time-Delivery (OTD) and Right-First-Time (RFT) KPIs.

Continuous improvement, based on a detailed customer satisfaction analysis with the objective to understand client perception, anticipate issues and implement or verify efficiency of action plans.

Solution provided by PLG

TEAM

An optimized organization combining expertise, competitiveness and proximity:

  • Dedicated case management team of 8,5 ETP (4,75 case officers,
    2,25 data managers, 1,5) based in Tunisia
  • 0,14 ETP for literature in France
  • 2 back-up case management in France
  • Coordinator (TU) and project manager (FR)
  • An appropriate governance with flowing communication

TOOLS

  • Activities delivered under the company’s processes with PLG proactive optimization trails
  • Experienced use of the company’s Argus safety database
  • A tailored tracking tool
  • iTAPsolution for Eudravigilance cases

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PV Support Credentials related to the RFP