Experts in the field

Managing pharmacovigilance, medical information and quality complaints

We manage pharmacovigilance (PV), medical information and product quality issues in the EU for a post marketed, global product. Our PV and Medical Information teams have developed expert knowledge of the product to provide a high quality, holistic service on behalf of our USA-based client.

Our service

We apply our expertise to deliver a complete service which includes:

  • PV case processing and reporting in the EU
  • PV global literature monitoring and scientific review
  • Aggregate reporting such as the Periodic Benefit-Risk Evaluation Report (PBRER)
  • A Qualified Person for Pharmacovigilance (QPPV)
  • Managing a Local Qualified Person for Pharmacovigilance (LQPPV) in each EU country
  • Provision of the Pharmacovigilance System Master File (PSMF)
  • Signal detection
  • Managing medical information queries for the EU
  • Processing EU product quality complaints and customer response letters.

Advantages

  • Efficiency – Key functions support each other, with many inter-linked tasks.
  • Relationships – We have built excellent relationships with our client and their customers.
  • Expertise – By applying good pharmacovigilance practices (GVP) we bring EU expertise and additional PV support to our client’s PV team in the USA.

Outcome

We deliver an effective, compliant EU PV function, that provides our client a complete solution and offers an excellent service to their customers.

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