WONJA
Course catalogue
Safety and pharmacovigilance

Pharmacovigilance Essentials

Adverse event handling, seriousness and causality assessment, expedited reporting and safety narratives.

Level
Intermediate
Length
8 hours
Lessons
12
Format
Self-paced

What you will be able to do

  • Assess seriousness, severity and causality
  • Meet expedited reporting timelines
  • Write a clear safety narrative
  • Reconcile safety and clinical databases

Course content

4 sections · 12 lessons · 8h total

Requirements

  • A working understanding of ICH-GCP and study conduct
  • Helpful, not required: exposure to adverse event handling

Who this is for

  • Safety, pharmacovigilance and site staff handling events
  • Coordinators responsible for reporting timelines
  • Study teams accountable for participant safety

Description

Adverse event handling, seriousness and causality assessment, expedited reporting and safety narratives.

Written for people already working near this topic who need sharper practice. You work through 4 sections built around the tasks the role actually asks for, each with a short worked example and a checkpoint so you can tell whether the material has landed.

This sits in Safety and pharmacovigilance: Adverse events, reporting and signal work. When you are ready to show the capability rather than describe it, the next step is Participant safety domain evidence.

Where it leads

Participant safety domain evidence. Completing a course builds capability. It does not by itself create Passport evidence: demonstrated work in Wonja Labs does.

See how Labs turns work into evidence

Common questions

Is this course assessed?
No. Checkpoints are for your own confidence. Assessed, reviewed work happens in Wonja Labs casebooks.
Does finishing this course create Passport evidence?
No. Courses build capability. Passport evidence comes from demonstrated work that is scored and reviewed in Wonja Labs.
Can I buy this on its own?
Yes. It is available as a single course, and it is also included in the Wonja Academy subscription alongside every other course and Labs access.
How long do I have to complete it?
It is self-paced with no deadline. Most people spread the material over two to three weeks alongside work.

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