Signal to Action
A report of harm reaches your company by an unexpected route. Decide how it is captured, assessed, reported and escalated — and what to do when the evidence is suggestive but not conclusive.
What a scenario is not
A scenario is a judgment exercise, not an assessment and not a compliance verdict. Finishing it evidences that you worked through it — nothing more — and the dimensions it scores are SPEQ’s, not any regulator’s.
Someone reports that a medicine may have harmed a patient. You decide what happens next, and how quickly.
Under Good Pharmacovigilance Practices the reporting clock runs from the organisation’s first awareness by anyone, individual cases feed signal detection, and a signal is evaluated on the evidence rather than on how inconvenient it is.
Pharmacovigilance fails quietly. Nothing visibly breaks when a case is captured late or a weak signal is set aside — the cost lands on patients who were prescribed the medicine while the question stayed open.
You work in pharmacovigilance for a marketing authorisation holder. A sales colleague forwards you an email from a physician describing a serious reaction.
Each decision changes what arrives next. Choose what a system in control would actually do.
The email came to a sales representative four days ago and reached you today. It describes a serious, unlisted reaction in a named patient. What do you do first?
This is a judgment exercise, not a quiz: your choices change the situation. It is scored across timeliness · assessment · governance · evidence — the same dimensions an inspector effectively weighs when they follow the thread of a real deviation. There is no compliance verdict here; the debriefs explain consequences.
Finishing this exercise is recorded. What it evidences — and the things it does not — is set out against the published standard.
What this evidences →