Global Pharmacovigilance Services

Safety Database

QVigilance offers set up and hosting of AB Cube SafetyEasy Database, which avoids the cost and delay of setting up a compliant safety processing system in-house.

Case Processing & Reporting

Case processing is performed by qualified and highly trained pharmacovigilance staff following clear and comprehensive internal procedures and using our validated Argus 8.1 database.

Aggregate Reports

The periodic reporting of aggregate safety reports provides National Competent Authorities with a comprehensive safety profile overview of a drug based on the collated evidence to date.

Literature Screening

We run a medical literature search for specific purposes or for ongoing screening of worldwide literature as required by local and regional requirements.

Regulatory Intelligence

Our team continuously monitors regulatory information from local, regional and global authorities for PV-related regulatory intelligence to ensure our customers are up to speed and maintain compliance.

Signal Management

QVigilance procedures on ongoing periodic Signal Detection & Management are written in accordance with GVP: Module IX, and is applied to products both pre- and post-authorisation.