[ CAREER PATHWAY · FREE ]
Pharmacovigilance — career pathway
The function that watches medicines in the real world — collecting, assessing, and reporting adverse events, and managing safety signals across the post-approval lifecycle.
What a pathway is not
A pathway is a reading route, not a qualification. Completing one evidences that you read it, and SPEQ says exactly that on the credential.
What the function does
Watches medicines in real-world use — collecting, triaging, and reporting adverse events, and running the safety database that holds them.
Turns individual cases into signals: aggregate reporting, signal detection and evaluation, and risk-management updates across the post-approval lifecycle.
- Pharmacovigilance Associate / Case Processor — Intakes, triages, codes, and submits individual case safety reports (ICSRs) within regulatory timelines.
- Drug Safety Associate — Supports reconciliation, literature screening, and aggregate-report preparation under the PV system.
- Intake and triage adverse-event cases from all sources, and enter them accurately in the safety database.
- Code events with MedDRA and submit ICSRs to authorities within the required timelines.
- Reconcile cases across sources (partners, literature, studies) and support aggregate safety reports.
- Flag potential signals and support signal evaluation and risk-management activities.
The regulations and standards this pathway anchors on. SPEQ decodes and cites each one; the authoritative text lives at the official source.
- EU GVP ModulesEU Good Pharmacovigilance Practices (GVP)EMA · last revised 2017-01-01
- 21 CFR 314.80Postmarketing Reporting of Adverse Drug ExperiencesFDA · last revised 2023-01-01
- ICH E2B(R3)Electronic Transmission of Individual Case Safety Reports (ICSRs)ICH · last revised 2012-11-01
- ICH E2AClinical Safety Data Management: Definitions and Standards for Expedited ReportingICH · last revised 1994-10-27
Know · collaborate · escalate
- What is a valid, reportable case (the four minimum criteria)
- The reporting timelines (expedited vs periodic)
- How MedDRA coding drives detection
- Triage seriousness and expectedness correctly
- Submit ICSRs within the clock
- Reconcile case sources completely
- Case assessment with medical reviewers
- Signal evaluation
- Aggregate-report preparation
- A potential safety signal
- A missed or at-risk reporting deadline
- A suspected under-reporting from a partner
- Never assume a non-serious case does not still need reporting
- Never assume the reported term is the right coded term
- Regulatory Affairs — safety-driven variations and label updates
- Clinical / Medical — case assessment and benefit-risk
- Quality Assurance — PV system audits and CAPA
Your first 30 / 60 / 90 days
9 steps
FIRST 30 DAYS
BY 60 DAYS
BY 90 DAYS
- Missing a reporting clock because a case was under-triaged at intake.
- Coding to the reported term instead of the correct MedDRA concept.
- Treating reconciliation as a formality rather than the guard against missed cases.
- Case-assessment and medical judgement
- Signal detection and evaluation
- Aggregate reporting and benefit-risk writing
- PV system and audit readiness
- Own the safety database and the PV system
- Support the QPPV and the benefit-risk position
- Represent safety to authorities and partners
WHERE NEXT
- START WITH THE BASICSRegulated Industry Foundations →Ten short modules, free, then an assessment and a credential.
- MEASURE ITSee the competencies this work builds →
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