What a role map is not
A role map is orientation — not a job description, a competency framework, or a statement of what any employer expects of you.
You help collect and report side effects from medicines so regulators and patients learn about safety problems quickly.
You intake, triage and process adverse-event cases in a validated safety database, code them consistently so signals can be detected across cases, and submit individual case safety reports within the required timelines under Good Pharmacovigilance Practice. The clock usually starts at the organisation’s first awareness by anyone, not at the safety team’s awareness, which is why intake from every channel is part of the obligation.
You keep the safety signal flowing — the system that catches what the trials could not see, because a trial of a few thousand subjects cannot detect a reaction that occurs in one of fifty thousand. A late report is not a paperwork failure; it delays a decision someone was relying on.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
In pharmacovigilance / drug safety, across the post-approval lifecycle and every market.
- Market supply and use of the product
- Case intake from patients, healthcare professionals, and literature
- Signal evaluation and risk-management updates
- Authority safety reporting (ICSRs and aggregate reports)
- Case intake sources and the validated safety database
- Medical coding dictionaries (MedDRA)
- The reference safety information
- The Qualified Person for Pharmacovigilance (QPPV)
- Regulatory Affairs (for safety-driven variations)
- Case intake, triage, and data entry
- On-time individual case safety report submission
- Reconciliation of case sources
- Deciding a benefit-risk change
- Signing the aggregate safety reports
- The pharmacovigilance lead and the QPPV
- Immediately, for a potential safety signal or a missed reporting deadline
- Individual case safety reports (ICSRs) submitted on time
- Case reconciliation records
- Case-processing and quality-check records
WHAT THIS ROLE CAN EVIDENCE · 1
Mapped to this role in the published registry. Nothing on this site assesses them yet, so this is what the standard says the work involves — never a claim about you.
A role map is Locate, moment 2 of 5: what surrounds your work, what you own, and what you escalate. It does not teach the practice or test it. Next is Learn — the Pharmacovigilance pathway, then Practise in a scenario, then what any of it evidences. Skip any of them — the order does not change.
ENTERPRISE CAPABILITIES YOU WILL ENCOUNTER
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 2013-01-01
- ICH E2AClinical Safety Data Management: Definitions and Standards for Expedited ReportingICH · last revised 1994-10-27