Pharmacovigilance (PV) isn’t only a compliance exercise–it demonstrates ongoing commitment to patient safety, and can be a powerful tool for approval of a biopharmaceutical. We’ll help you find the optimum approach which combines quality and reliability with efficiency.

 

Seeking external support with PV delivery has become common practice due to soaring workloads. As regulators demand more data to understand safety signals, internal teams find themselves increasingly stretched. We can help in a number of flexible and customizable ways – with solutions ranging from flexible staffing/short-term tactical support to long-term strategic partnership.

 

A rounded approach to PV that delivers on all points

 

We can provide PV support in any or all of the following areas:

  • ICSR management – including collection, evaluation, processing, distribution & reporting
  • Safety database hosting and support
  • Literature monitoring
  • Pharmacoepidemiology
  • Signal management
  • Risk management
  • Periodic safety reports
  • Pharmacovigilance system and compliance
  • EU-QPPV / local QPPV
  • Quality system, audit and inspection support
  • Safety data exchange agreements

 

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28.06.23
Steve

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    PharmaLex is now part of Cencora, a leading global healthcare company with a foundation in pharmaceutical distribution. In 2024 and beyond PharmaLex and all the companies in PharmaLex family will begin a journey to becoming Cencora as well. Cencora brings the companies and services together under one new name. The name will change, but the level of attention and service you receive remains the same.  

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