drug safety associate training

The activity that is most commonly associated with pharmacovigilance and which consumes a significant amount of resources for regulatory authorities, is that of 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. The source of AE reports may include: spontaneous reports,solicited reports; reports from clinical or post-marketing studies; reports from literature sources; reports from the media and reports reported to drug regulatory authorities themselves. For pharmaceutical companies, AE reporting is a regulatory requirement in most countries. AE reporting also provides data to these companies and drug regulatory authorities that play a key role in assessing therisk-benefitprofileof agivendrug.