Pharmacovigilance is defined as gathering drug safety related clinical data in daily clinical practice, to monitor, detect, understand causes of, investigate, communicate and prevent Adverse Drug Reactions. Pharmaceutical companies’ pharmacovigilance processes are managed on electronic environment with QMex.
QMex Pharmacovigilance module enables recording and evaluating Adverse Reaction/Event reports, preventing double reporting, monitoring and performing causality investigations and recording MeDRA information.
The module, operating in integration with Customer Complaints module, automatically links complaint reports which need to be investigated for adverse reactions together.
Product specific (PBRER “Periodic Benefit-Risk Evaluation Report”) and clinical trial related (SUSAR “Serious Unexpected Serious Adverse Reactions” and ASR “Annual Safety Report”) reports required to be performed by Pharmacovigilance departments are executed with this module.