An adverse event report is simple to describe and surprisingly easy to mishandle. Following one case from receipt to submission shows where a safety system is strong and where it leaks time.
The journey of a case
- Receipt and triage: log the report, establish the four minimum criteria (identifiable reporter, identifiable patient, suspect product, adverse event) and start the clock.
- Data entry and coding: capture the case in the safety database and code events and products consistently.
- Medical review: assess seriousness, causality and expectedness against the reference safety information.
- Reporting: submit to the relevant authorities within the required timelines, then follow up for missing information.
- Archive and trend: keep the complete audit trail and feed cases into signal detection.
Where time is lost
- Unclear clock-start: the team cannot say when the company first became aware of the case.
- Follow-up that waits: queries to reporters sent days after they could have been.
- Inconsistent coding: the same event coded three ways, which hides signals.
- Local reports that never reach the global database.
Most delays are process problems, not people problems. A clear definition of day zero, a shared follow-up template and a weekly reconciliation of local and global case counts resolve the majority of them.
Our pharmacovigilance team supports adverse-event reporting, safety-database management and periodic reports across African markets.
