How to Appoint a Qualified Person for Pharmacovigilance
Put a named, contactable, empowered person behind the safety of your products.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
The qualified person responsible for pharmacovigilance is a named individual accountable for the establishment and maintenance of the pharmacovigilance system. The appointment is straightforward to make and easy to make hollow: a name on a form, without the authority, information flow and availability the role requires, is the shape of the finding rather than its remedy.
- 1
Establish the qualifications and confirm them
Confirm the individual has the qualifications and experience the role requires, and record the evidence. The appointment file, not the job title, is what demonstrates suitability.
- 2
Define the authority the role carries
Document the authority to influence the safety of products, including the ability to require action and to escalate outside the ordinary reporting line. A qualified person who can be overruled without record does not have the authority the role assumes.
- 3
Guarantee permanent availability
Put in place arrangements for continuous availability, including a deputy with equivalent standing and a documented handover. Availability is a standing obligation, not a best-efforts arrangement around leave.
- 4
Wire the information flows into the role
Ensure safety information reaches the qualified person from every function that might receive it — medical information, commercial, quality, partners. The role cannot discharge accountability for information it never sees.
- 5
Notify the authorities and keep details current
Register the appointment and contact details with the relevant authorities and update them when they change. A stale contact record is a real failure: it means an urgent safety communication has nowhere to land.
- 6
Record the appointment in the master file
Reflect the appointment, the deputy arrangement and the contact details in the pharmacovigilance system master file so the documented system and the appointment agree.
- !A named appointment with no documented authority to require action or escalate.
- !Deputy arrangements that exist on paper but with no handover or equivalent standing.
- !Safety information reaching the organisation through functions that never route it to the role.
- !Contact details registered once and never updated, so urgent communications have nowhere to land.
How to Appoint a Qualified Person for Pharmacovigilance: frequently asked questions
Common questions on appoint a qualified person for pharmacovigilance.
Can the role be held by someone outside the organisation?
Arrangements vary by jurisdiction, but wherever the role sits, the accountability of the marketing authorisation holder is unchanged and the person must have real authority and permanent availability. An external appointment with neither is weaker than an internal one, not stronger.
What does permanent availability mean in practice?
That the role is continuously covered — by the appointed person or a deputy of equivalent standing, with a documented handover. Safety issues do not wait for a return from leave, and an arrangement that cannot answer at short notice is not availability.
Why does the authority of the role matter so much?
Because accountability without authority is decorative. If the qualified person cannot require an action, halt a communication, or escalate past an ordinary reporting line, then the system has assigned responsibility to someone who cannot discharge it.