Process an Individual Case Safety Report the way an entry-level Drug Safety Associate does: confirm a report is a valid case, classify seriousness and expectedness, set Day 0 and the reporting clock, extract source information into structured case fields, assess causality with the Naranjo algorithm and the WHO-UMC system, write a chronological case narrative and recognise what a CIOMS-I form carries. It teaches the case-processing method that every safety database encodes; it is not Oracle Argus, ARISg or MedDRA software training.
What you will be able to answer
A hospital pharmacist emails your PV team: a 58-year-old man started a new antibiotic, developed a widespread rash and swelling of the lips on day 4, was admitted overnight, and recovered after the drug was stopped. The email gives his initials and age but no batch number, and mentions he also takes amlodipine. What can you produce before the case goes to medical review?
A processed case: a validity check against the four minimum elements with Day 0 recorded; a seriousness classification with the criterion that applies; an expectedness call stated against the named reference safety information; the resulting reporting clock; the source information placed into patient, reporter, suspect and concomitant drug, event, treatment and outcome fields with dechallenge recorded; a Naranjo score and a WHO-UMC category with the reasoning behind each; a chronological case narrative; and a list of follow-up questions for the reporter — without claiming a final medical causality judgment or inventing local regulatory deadlines.
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Course outline
Concept 1
Concept 1 · Follow one adverse-event report from intake to submission
Concept 2
After: pv-case-lifecycle
Before anything else, a case processor asks one question of every report: is there enough here to call it a case?
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Concept 3
After: valid-icsr-minimum-criteria
A crushing headache can be severe without being serious — and the difference decides how fast the case must move.
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Concept 4
After: seriousness-criteria
'Unexpected' doesn't mean surprising — it means the event isn't described that way in the document the company is held to.
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Concept 5
After: expectedness-reference-safety-information
The reporting deadline starts the moment the company first holds a valid case — not when it reaches your desk.
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Concept 6
After: valid-icsr-minimum-criteria
A safety database is only as good as the person reading the source: every field is a decision about what the reporter actually said.
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Concept 7
After: case-data-entry
Ten questions, each worth points, turn 'did the drug cause this?' into a score you can defend.
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Concept 8
After: naranjo-algorithm
WHO-UMC asks the same question as Naranjo without a score — and the two methods don't always agree.
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Concept 9
After: case-data-entry, who-umc-causality
A reviewer who never sees the source should be able to read your narrative and reach the same conclusion you did.
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Concept 10
After: icsr-narrative-writing
The processed case often leaves the building as a one-page form — and every field on it traces back to work you've already done.
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20 candidates did not meet the course criteria.
The single most common corporate landing spot for Pharm.D freshers in India. You process Individual Case Safety Reports (ICSRs) — extracting adverse-event data, assessing causality, coding with MedDRA, and writing safety narratives — inside CROs and IT-pharma units (TCS, Cognizant, Accenture, IQVIA). Your clinical training gives a genuine edge in causality assessment and narrative writing over B.Pharm competitors. Progression runs from case processing to aggregate reports (PSURs/PBRERs) to signal detection and PV management.
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