RECORDREFERENCE OUTLINE

QPPV Appointment and Authority Record

Appointment record that makes the QPPV role real rather than nominal: qualifications with evidence, authority stated in terms exercisable against resistance, permanent availability and a deputy with equivalent standing and a recorded handover, and the information flows from functions that hold no pharmacovigilance role. Maps to EU GVP Module I and Reg. (EU) 520/2012.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
EU GVP ModulesReg. (EU) 520/2012
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

The qualified person responsible for pharmacovigilance is a named individual personally accountable for the establishment and maintenance of the pharmacovigilance system. The appointment is straightforward to make and easy to make hollow: a title conferred without the authority to halt an activity, escalate to executive level, or require information from a function that reports elsewhere. This record states the authority in terms exercisable against resistance.

What's Inside

✓Appointment details, territorial scope, and the pharmacovigilance system master file reference that records the role
✓Qualifications mapped requirement by requirement to evidence, rather than attached as an undifferentiated curriculum vitae
✓Authority conferred, written in exercisable terms including access to data and escalation to executive level
✓Permanent availability arrangements, the named deputy, and the trigger that actually transfers the role
✓Deputy handover record, so a transfer of the role is evidenced rather than asserted in a procedure
✓Information flows from every function that may receive safety information, with training confirmed per route
✓Notification to the competent authority and the appointee’s signed acceptance of the responsibilities conferred

How to Use It

1Map each qualification requirement to a specific piece of evidence, so the appointment survives a challenge to competence
2State authority in terms exercisable against resistance — authority that exists only where nobody objects is not authority
3Record the deputy handover itself, not merely the deputy’s name; paper arrangements fail at the moment they are needed
4Map the route from every function touching safety information — sales, medical information, quality, legal, social media — and train each
5Keep the notified details and the master file in agreement, because a divergence between them is found in the first hour
6Review the appointment when portfolio, territory or organisation structure changes, rather than only when the person changes
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Appointment
2Qualifications
3Authority Conferred
4Availability and Deputy
5Information Flows Into the Role
6Notification and Acceptance
REGULATORY CONTEXT

EU GVP Module I sets the pharmacovigilance system requirements including the qualified person, permanent availability and the deputy arrangement, and Reg. (EU) 520/2012 the minimum requirements for the role and its documentation. Neither specifies how your organisation confers real authority, which reporting line protects independence, or what evidence proves a given qualification is met — those determinations belong to the marketing authorisation holder. The record structure and the exercisable-authority framing are SPEQ synthesis.

MAPPED STANDARDS
EU GVP ModulesReg. (EU) 520/2012
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