Diagnosis of the Pharmacovigilance function

Project description

The client wishes to conduct a diagnosis of the Global Pharmacovigilance to:

  • Secure the pharmacovigilance activities and de-risk products
  • Implement the new reporting line and perform a safe take-over
  • Preserve pharmacovigilance ecosystem

 

Project approach

  • Diagnosis of key processes and related recommendations
  • Assessment of the organization on several themes, including organizational chart, competencies and IS/IT
  • Identification of improvement areas regarding communication between global PV department and their counterparts

 

Results

  • Remediation plan on key processes, built by operational staff
  • Recommendations on organization, endorsed by decision makers
  • Action plan with identified accountabilities, timeframe, priorities and associated workload
  • Dashboard monitored by managers and decision makers
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