AgosIT PVG Database Safety

What is a Safety Reporting PVG Database?

A Safety Reporting PVG Database or PVGD is the main repository for product safety information, it enables the reporting of individual and collective safety data to regional/global authorities and third-party partners*.

*(where allowed/required)

The PVG database also provides a wealth of information for ongoing detection of safety issues and evaluating the risk/benefit balance of products. It is therefore imperative that the pharmacovigilance safety database is up to date with the latest reporting requirements and has been validated for use to ensure it meets the needs for regulatory compliance and business purpose.

Case reporting adverse reactions/events (SAEs, SUSARs, SESARs) associated with pharmaceutical products need to be collected in a central validated database which allows for electronic reporting to authorities in accordance with the E2B standard**.

**E2B is an international standard for transmitting medicine adverse event reports specified by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

For organizations that require their own Safety Reporting Pharmacovigilance Database/ PVGD AgosIT can help select, migrate, deploy, and manage a solution to fit your use and purpose.

Benefits Of Using AgosIT

  • Improve quality and efficiency through safety integration and automation.
  • Enhance compliance with E2B(R3) transfer and periodic reporting.
  • Conduct global case processing that scales from a few to millions of cases.
  • Offering dedicated cloud-based systems, there is no need for VPN access, as the system is accessible anywhere in the world via web address.
  • Global Managed Support is available.

How AgosIT Help To Select Your System:

  • AgosIT tailor vendor selection for GxP software solutions which help organizations choose the right platform for their needs.
  • We give advice on good software solutions providers with a focus on high availability.
  • AgosIT support in choosing, designing, implementing, validating and maintaining your software solution.
  • We can create software user and admin guides/ SOPs.
  • We perform in-house user training.
  • AgosIT provide Pharma and Technical advice on how to implement ICH E2B(R3) specification for pharmacovigilance case reports.

Consulting with a professional partner like AgosIT can help you understand these considerations, enabling you to find the right solution.

To find out more on AgosIT’s GxP software solutions contact us today.

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