Pharmacovigilance
Lab Curriculum.

BUG FOUND: learners who know drug safety terms, but cannot handle a real adverse-event case correctly.

$ step-01 brushup // weeks 1–2 — Topics taught:

1. Drug safety basics: adverse events, seriousness, and expectedness concepts.
2. Case basics: patient, drug, event, reporter, and timeline.
3. Causality assessment basics.
4. MedDRA coding concepts for events and drugs.
5. Reporting basics: what must be reported, to whom, and by when.
6. Follow-up basics: what information is missing, and how to ask for it.

$ step-02 debug // weeks 3–4 — Production Debugging. Tools: sample adverse-event cases, safety database concepts, reporting templates.

• BUG #1: Adverse-event error: a case is coded to the wrong event term — find it, correct it, document the reason.
• BUG #2: Incomplete case: a serious case lacks key data — identify what is missing, draft a follow-up request.
• BUG #3: Wrong causality / seriousness assessment — reassess with evidence, document the reasoning.
• BUG #4: Duplicate case: the same event is reported twice — detect the duplicate, merge / link correctly, document it.

$ step-03 navigate // weeks 5–7 — Codebase / System Navigation:

• Navigate a safety database and cases: trace a case from report to assessment to submission.
• Follow up missing data across multiple cases, prioritising by seriousness.
• Audit a case set for coding, causality, and timeliness errors; rank by risk.
• Review a peer's case assessment for evidence, consistency, and completeness.

$ step-04 ship // weeks 8–9 — Shipping Features: capstone — audited safety-case reports with a follow-up plan, presented as if to a safety reviewer.

$ ship → PROOF — exact output: audited safety-case reports, follow-up plan, and an error summary.

$ run --lab pharmacovigilance → ✓ SHIPPED, job-ready