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 are the person European regulators contact about the safety of your company’s medicines, and your name is on the record. If the safety system does not work, that is yours.
You establish and maintain the pharmacovigilance system, own the Pharmacovigilance System Master File that describes it, oversee the safety profile of every authorised product, and act as the single point of contact for the competent authorities and for inspection. Good Pharmacovigilance Practices set the expectations; the position itself is a legal requirement on the marketing authorisation holder, not an internal title it can define.
The role exists because a system with everyone responsible has nobody responsible. Naming one person to the authority makes a diffuse obligation attachable — and means the answer to "who decided the signal did not warrant action" is never "the process".
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
At the top of the pharmacovigilance system, between the marketing authorisation holder and the competent authorities of every Member State it operates in.
- Case intake, processing and signal detection
- The marketing authorisation and its conditions
- Regulatory action on a safety signal
- Authority inspection of the pharmacovigilance system
- Case processing that captures every source, on time
- Signal detection with a method that can be described and defended
- Affiliates and partners reporting into the system rather than around it
- The marketing authorisation holder, whose obligation is discharged through this position
- Competent authorities relying on a single reachable point of contact
- Prescribers and patients, downstream of every signal decision
- The pharmacovigilance system and the Master File that describes it
- Oversight of the safety profile of every authorised product
- The judgement that a signal requires action, and the record of why
- The marketing authorisation itself
- Regulatory action, which is the authority’s
- Clinical or commercial decisions about the product
- The marketing authorisation holder’s management, where the system lacks resource to meet its obligation
- The competent authority, where an urgent safety issue requires it
- The Pharmacovigilance System Master File and its change history
- Signal evaluation records with the reasoning, not only the conclusion
- Periodic safety reports and the responses to authority questions
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