[ 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.

TYPICAL ENTRY ROLES
  • 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.
CORE RESPONSIBILITIES
  • 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.
SOURCE PACK · 4 PRIMARY SOURCES

The regulations and standards this pathway anchors on. SPEQ decodes and cites each one; the authoritative text lives at the official source.

Know · collaborate · escalate

SHOULD KNOW
  • What is a valid, reportable case (the four minimum criteria)
  • The reporting timelines (expedited vs periodic)
  • How MedDRA coding drives detection
SHOULD DO
  • Triage seriousness and expectedness correctly
  • Submit ICSRs within the clock
  • Reconcile case sources completely
COLLABORATE ON
  • Case assessment with medical reviewers
  • Signal evaluation
  • Aggregate-report preparation
ESCALATE
  • A potential safety signal
  • A missed or at-risk reporting deadline
  • A suspected under-reporting from a partner
NEVER ASSUME
  • Never assume a non-serious case does not still need reporting
  • Never assume the reported term is the right coded term
WORKS WITH
  • 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

FIRST 30 DAYS
  • Complete the Foundations series
  • Learn your safety database and case workflow
  • Understand the reporting timelines
BY 60 DAYS
  • Process cases end to end under review
  • Run a reconciliation cycle
  • Read the GVP modules that govern your work
BY 90 DAYS
  • Own case processing for a product
  • Support an aggregate report
  • Raise and document a potential signal
COMMON EARLY MISTAKES
  • 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.
SKILLS TO ADVANCE
  • Case-assessment and medical judgement
  • Signal detection and evaluation
  • Aggregate reporting and benefit-risk writing
  • PV system and audit readiness
LEADERSHIP RESPONSIBILITIES
  • Own the safety database and the PV system
  • Support the QPPV and the benefit-risk position
  • Represent safety to authorities and partners
RECOMMENDED SPEQ SEQUENCE
PRACTISE IN A SCENARIO