• Pharmacovigilance

    Also known as drug safety, Pharmacovigilance is the science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.


The business request was to design a new IT System build in compliance with the Pharmacovigilance EU regulations (Module IX). The challenge was to build a new web application and to migrate the old cases with a minimal impact on user’s activity.

*** The Module is applicable to medicinal products for human use authorised in the EU irrespective of the authorisation procedure (centralised or national procedure, including mutual recognition and decentralised).


Developed a new IT System that ensures consistent tracking of safety signals and risks, with signal validation, evaluation steps and decision making processes.

The solution was build to reduce the number of applications used for safety signals management.

The application contains a repository where all safety signals, actions and documentations related to the signal management process are stored.

The application presents a Reporting section where users can generate:

  • Periodic reports for signal detection and evaluation
  • Periodic extracts of signals created or updated for Pharmacovigilance awareness
  • Various reports of QC and compliance


The solution is successfully used by more than 300 users in France and United States of America. It reduced the time to create and process safety signals. User experience was improved:

  • Users are working in one centralised application. Before they had to use multiple systems in order to create, manage and track safety signals.
  • Users receive periodic reports sent automatically by the system. Before they had to generate each report by hand and accessing different systems.
  • Users have the option to configure the Notification process and reports.
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