pharmacovigilance certification

Pharmacovigilance, or drug safety, is the pharmacological science relating to collecting, detecting, assessing, monitoring, and preventing adverse effects with pharmaceutical products. The activity most commonly associated with pharmacovigilance and consumes a significant amount of resources for regulatory authorities is adverse event reporting. Adverse event (AE) reporting involves the receipt, triage, data entering, assessment, distribution, reporting (if appropriate), and archiving of AE data and documentation.