Pharmacovigilance and Drug Safety (PV) Training

One Case at a Time, and Why Each One Counts

The drug safety desk, from the report arriving to the label changing: what pharmacovigilance is for, where cases come from and what makes one valid, day zero and triage, building a case from an incomplete report without inventing the missing parts, the three assessments that decide everything downstream (seriousness, causality and expectedness), the seven and fifteen day clocks, what does not expedite and why periodic reporting is not the lesser half, MedDRA coding and narrative writing, and how individual cases become a signal and then a decision.

30 lessons, about 45 minutes. Free, in your language.

What the Safety Desk Is For

Intake and Triage

Processing the Case

Seriousness

Causality

Expectedness

The Reporting Clock

What Does Not Expedite

Coding and the Narrative

Signal Detection and Risk