Recognises when a report becomes a reportable case, that the clock runs from the organisation’s first awareness by anyone, and that seriousness is a property of the event rather than of a causality view.

WHAT IT LOOKS LIKE · 5

• Captures the four elements that make a report a valid case, and pursues the missing one rather than discarding the report.
• Applies the reporting clock from the first day anyone in the organisation became aware, not from when the case reached the safety team.
• Codes the event to what was described rather than to the nearest convenient term, preserving the reporter’s meaning.
• Follows up a case to resolve outcome and causality instead of closing on the initial report.
• Recognises when a pattern across cases has become a signal, and routes it for evaluation rather than filing each case separately.

HOW IT IS DEMONSTRATED AT WORK

The evidence is in timeliness and in follow-up quality: cases submitted inside their timeline with the awareness date defensible, follow-up that actually changed what was known, and at least one instance where this person escalated a pattern rather than processing a case. Late cases are the visible failure; the quiet one is a hundred on-time cases that each lost the reporter’s description to convenient coding.

WHERE IT IS COMMONLY WEAK

Day zero is the recurring problem. Awareness anywhere in the organisation starts the clock — a sales call, a medical information line, a social media mention, a site’s own email — and the case commonly reaches pharmacovigilance days after someone first knew. The second weakness is signal detection treated as a periodic statistical exercise, so an individually unremarkable series of cases is never looked at as a series.

WHAT TEACHES IT · 1

• CAREER PATHWAYPharmacovigilance — career pathway

WHAT EXERCISES IT · 0

Nothing exercises this yet. 10 scenarios are published and none is linked to this entry — we would rather say so than point you at the closest one.