A day in the life of a pharmacovigilance case processor

Abstract

Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word “pharmacovigilance” are “Pharmakon” (Greek for drug) and “Vigilare” (Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

Keywords

• Causality
• coding
• duplicate search
• expectedness
• Medical Dictionary for Regulatory Activities
• Suspected Unexpected Serious Adverse
• triage