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 collect and assess reports of things going wrong with animal medicines — in the animal, in the person giving it, and in the food chain — and make sure regulators hear about them.
You run adverse-event intake and assessment for veterinary medicinal products, covering suspected lack of expected efficacy, reactions in the treated animal, human exposure during handling or administration, environmental effects, and residues appearing where a withdrawal period should have cleared them. Regulation (EU) 2019/6 governs the European framework; FDA’s Center for Veterinary Medicine takes the equivalent reports in the United States.
Veterinary safety surveillance has a wider aperture than human pharmacovigilance and a thinner reporting stream. The categories that have no human analogue — human exposure to an animal product, a residue in the food chain, an environmental effect — are the ones nobody thinks to report, so the system has to actively ask.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
Between the veterinarians, producers and owners who observe events and the authorities that act on them.
- Marketing authorisation of the veterinary product
- Use in the field, which is where the data comes from
- Regulatory action on a veterinary safety signal
- Label or withdrawal-period change
- Veterinarians and producers recognising an event as reportable at all
- Product quality data, where a suspected failure may be a manufacturing issue
- Regulatory affairs for what the authorised label and withdrawal period actually say
- Competent authorities relying on the signal reaching them
- Veterinarians prescribing on the current safety understanding
- Food-safety authorities where a residue signal appears
- Intake, assessment and reporting of veterinary adverse events within required timelines
- The judgement that a report indicates a signal rather than an isolated event
- Escalation where human exposure or a food-chain residue is involved
- The prescribing decision or the treatment
- The authorised withdrawal period, which is a regulatory approval
- Product recall decisions, which sit with quality and the authority
- Quality assurance, where an event suggests a batch or manufacturing cause
- The competent authority, where human or food-chain exposure is indicated
- Adverse-event case records including human exposure and environmental categories
- Signal assessments and the reasoning behind each conclusion
- Periodic safety reporting for authorised veterinary products
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.
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