Orientation only. SPEQ does not assess or confer standing for a named regulatory position; the level describes the competency’s subject, not an attainment SPEQ has verified.
Indicates orientation only. It is not a qualification, license, or certification, and does not replace employer training, supervision, or professional judgment.
WHAT IT LOOKS LIKE · 6
- Holds an accurate overview of the system — its processes, obligations and where they are performed — and can state where it is currently weak.
- Maintains the description of the system as a live document, so it describes what happens rather than what was intended at registration.
- Oversees delegated and outsourced activities as still owned, with visibility of performance rather than assurances of it.
- Ensures the safety profile is kept under continuous review and that a signal reaches a decision within a defensible time.
- Escalates a system deficiency to the governing body with its consequence stated, rather than managing it quietly.
- Is contactable and answerable for the system, in person, at any time it is operating.
HOW IT IS DEMONSTRATED AT WORK
The role is demonstrated by what its holder can evidence about the system: current deviations from the described system, the open CAPAs and their age, the audit findings and their status, and the performance of every party the system depends on. A holder who can describe the intended system but not its current deficiencies is fulfilling the appointment rather than the responsibility.
WHERE IT IS COMMONLY WEAK
Two failures, and both are structural rather than personal. The first is a description of the system that has drifted from reality — sites, vendors, processes and contact points that changed without it — which is the first thing an inspector compares against what they find. The second is oversight without instrumentation: activities delegated to affiliates or vendors with contracts in place, reports arriving, and no independent way to know whether cases are being collected at all.
WHAT TEACHES IT · 1
- CAREER PATHWAYPharmacovigilance — career pathway
WHAT EXERCISES IT · 0
Nothing exercises this yet. 10 scenarios are published and none is linked to this entry — we would rather say so than point you at the closest one.
See what your own record shows against this entry — and what it does not.
Where you stand →