Pharmacovigilance Safety Database Services

A Global Pharmacovigilance Safety Database sits at the heart of the vigilance system for medicinal products and devices. It is the main repository for collected safety information for the company’s product(s), it facilitates the reporting of individual and aggregate safety data to authorities and third parties and provides a key source of information for ongoing detection of safety signals and evaluating the risk-benefit balance of the product. It is therefore vital that the pharmacovigilance safety database is up to date with the latest reporting requirements, and has been validated to ensure it meets the needs for regulatory compliance and business purposes.

QVigilance offers a fully managed and maintained safety database solution with AB Cube SafetyEasy Database. Providing significant cost savings, otherwise incurred with the implementation and maintenance of in-house systems and their expensive downstream upgrades, to maintain compliance with ever-changing regulatory expectations.

Experience across multiple PV safety Databases:

  •    Argus
  •    ARISg/LifeSphere Safety
  •    Aris Global IRT
  •    PV Works
  •    SafetyBase Interchange
  •    Own In-house customers systems and require case
       processing, reporting and aggregated data retrieval


AB Cube SafetyEasy Database

QVigilance’s AB Cube SafetyEasy Database is fully validated, 21 CFR Part 11 / Eudralex Annex 11 and native E2B(R3) compliant. We provide each customer with a specific safety database instance to ensure full segregation and confidentiality of data. The web-based interface enables customers to securely access the database for increased oversight of their data. At project start, the database instance will be configured with the company, study and product details and reporting requirements. Workflows are managed within the database, allowing configuration of customer specific timelines and requirements. Case reports are produced directly from the application according to regulatory standards. Validated aggregate case listings and tabulations are generated via built-in query and reporting functionality for periodic reports and benefit-risk analysis.

Why choose us for your pharmacovigilance safety database?

QVigilance' safety database is maintained on an ongoing basis in accordance with robust change management procedures and includes MedDRA and WHO DD updates, MedDRA recoding, patches, and upgrades, so ensuring the system is continuously achieving regulatory compliance.

Our tailored solutions can take on full, end-to-end case processing activities, or hybrid approaches with direct customer input into workflows.

The QVigilance PV team have extensive user-end training and are experienced in using the system to its full potential. Our goal is to support customers whatever stage of the product lifecycle they may be at, from managing the risk-benefit profile of products on the market to helping bring drugs to market. All this must be done whilst meeting strict regulatory requirements and a fully validated comprehensive safety database is a fundamental part of achieving this.

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