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Pharmacovigilance & MedDRA Foundations

Adverse-event reporting from the ground up: what makes a case valid, how causality is argued, and how events and drugs are coded in MedDRA. Two hours, and it is the single course most often named in the safety roles on this board.

2 hours12 lessonsNo prior industry experienceCertificate on completion

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What it moves on your score

SkillsSpecialty relevanceCareer-transition feasibility

What you can do afterwards

Decide whether a report is a valid adverse-event case

Argue causality against company core safety information

Code an event and a drug in MedDRA to the right level

Write a case narrative a medical reviewer can assess

Curriculum4 modules · 12 lessons

What a case actually is

1The four elements of a valid caseVideo11:00

2Serious, severe and expected: three different wordsVideo9:00

3Reference sheet: validity and seriousness criteriaNotes

Causality

4WHO-UMC categories and how they are arguedVideo14:00

5Working a case against core safety informationVideo12:00

6Reference sheet: causality worked examplesNotes

MedDRA

7The hierarchy: LLT, PT, HLT, SOCVideo13:00

8Choosing the right lowest-level termVideo15:00

9Coding assessment: twelve eventsAssessment20:00

The narrative

10Chronology, not commentaryVideo10:00

11Reference sheet: narrative templateNotes

12Medical reviewer assessmentAssessment25:00

Taught by

Dr. Nithya Balakrishnan

Medical reviewer, Aarogya Life Sciences

Moved from a Chennai medicine unit into drug safety in 2023.

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