Blog

Pharmacovigilance Data: challenges for Pharmaceutical Companies

Written by Daniela Rota | Jun 10, 2021 9:00:00 AM

Pharmaceutical companies are asked every day to collect pharmacovigilance data in a structured format and handling them following a defined workflow in secure and validated environment. The number of data to be collected is ever greater (consider, for example the amount of vaccine ADRs) and the requirements for its handling are increasingly demanding.

Pharmacovigilance database suppliers are evolving more and more to make their products capable, safe and in compliance with such requirements. Data should be structured in a way they can be analyzable in aggregate reports and signal detection activities by the company itself and competent authorities.

The company must therefore have the ability to keep up with the requirements, selecting the tools and suppliers that best meet its internal needs but at the same time keep up with technological and regulatory developments.

Among the biggest challenges facing the pharmacovigilance department in this period regard:

  • data format
  • data location
  • data migration