This blog features:
- Who a QPPV is – Understanding the role and significance of the Qualified Person for Pharmacovigilance.
- QPPV and LPPV – Exploring the differences and relationship between global and local pharmacovigilance roles.
- Roles and Responsibilities of a QPPV – Detailing the key duties, legal obligations, and regulatory expectations of the position.
Table of Contents
Introduction
This blog provides a clear and concise overview of the Qualified Person for Pharmacovigilance (QPPV) — what the role entails, its key responsibilities, and the scope of its authority.
It also highlights the distinctions between QPPV and LPPV (Local Person for Pharmacovigilance), offering essential insights into how these roles function within a pharmacovigilance system.
In short, this guide walks you through all the critical nuances you need to understand about the QPPV role and its significance in ensuring drug safety compliance. Let’s dive in!
QPPV and LPPV: An Overview
QPPV: The term QPPV stands for Qualified Person for Pharmacovigilance. This concept was first introduced in the European region, establishing the requirement that every Marketing Authorization Holder (MAH) must have, at all times, a Qualified Person responsible for pharmacovigilance. The QPPV ensures that the company’s pharmacovigilance system operates in full compliance with applicable regulations and that the safety of medicinal products is continuously monitored.
LPPV: The term LPPV stands for Local Person for Pharmacovigilance (also referred to as Local QPPV, National QPPV, or Local Safety Officer, depending on the region or organization). The LPPV serves a similar role to the QPPV but operates at the country or regional level outside the EU. This role ensures that local pharmacovigilance activities comply with national regulatory requirements and that there is an effective liaison between the company and the local health authority.
“Behind every safe medicine is a QPPV whose decisions protect millions.”
Legislation
The European Union (EU) legislation defines the Qualified Person for Pharmacovigilance (QPPV) as having specific legal responsibilities within the European Economic Area (EEA). The QPPV holds primary accountability for ensuring that the Marketing Authorisation Holder (MAH) maintains a pharmacovigilance system that fully complies with EU regulatory requirements.
The obligations of the EEA QPPV are established under Regulation (EC) No. 726/2004 and Directive 2001/83/EC (as amended). Comprehensive guidance on the QPPV’s roles and responsibilities is provided in Volume 9A, Part I, Section 1.2 of the EU Guidelines on Good Pharmacovigilance Practices (GVP).
These legal responsibilities also extend to companies registering traditional herbal medicinal products within the EU, as outlined in Directive 2004/24/EC.
Qualifications for the QPPV Role
Below are some key points to understand if you aspire to become a Qualified Person for Pharmacovigilance (QPPV) or are responsible for appointing one in a company:
- It is the responsibility of the Marketing Authorisation Holder (MAH) — or a group of MAHs sharing a common pharmacovigilance system — to formally appoint a QPPV.
- The MAH must provide adequate resources and support to enable the QPPV to effectively perform their duties.
- The QPPV must have sufficient authority to initiate and implement necessary changes to the company’s pharmacovigilance system to ensure ongoing regulatory compliance.
- A summary curriculum vitae (CV) of the QPPV should be maintained, including relevant qualifications, training, and professional experience.
- The EEA QPPV must reside and perform their duties within the European Economic Area (EEA).
- The QPPV should possess a thorough understanding of EU pharmacovigilance legislation and guidance, as well as international PV standards and practices.
- It is recognized that the QPPV’s role can be demanding and multifaceted, with the scope of responsibilities varying depending on the size and complexity of the MAH’s operations.
Note: There is no specific requirement regarding the number of years of experience needed to qualify as a QPPV. However, the individual must possess sufficient knowledge, training, and practical experience in pharmacovigilance to competently fulfill the responsibilities of the role.
Appointing a QPPV
The appointment of a QPPV must be formally documented, typically through a job description or a written agreement outlining the scope of responsibilities and authority.
A signed QPPV statement is required as part of the company’s Detailed Description of the Pharmacovigilance System (DDPS), which accompanies EU marketing authorisation applications. Importantly, a QPPV must not be appointed without their explicit knowledge and consent.
In certain EU Member States, national legislation mandates the designation of a locally responsible individual who holds specific legal obligations for pharmacovigilance at the national level. In such cases, this individual may also serve as the EEA QPPV, or the roles may be assigned to separate individuals, depending on the company’s structure and regulatory requirements.
The QPPV must receive appropriate training on the company’s pharmacovigilance system, and this training should be fully documented to demonstrate compliance and competency.
Having more than one EEA QPPV for a system is not acceptable because there must be one individual who is fully accountable
Roles and Responsibilities
Outlined below are the key roles and responsibilities of a Qualified Person for Pharmacovigilance (QPPV) as defined by regulatory expectations and good pharmacovigilance practices:
- The QPPV’s responsibilities may be managed through various operational models; however, the Marketing Authorisation Holder (MAH) is ultimately accountable for implementing an appropriate and compliant structure.
- The competency and adequacy of the company’s pharmacovigilance processes and procedures are subject to inspection by Competent Authorities.
- A QPPV may serve multiple MAHs, provided they can effectively fulfill all legal and operational obligations for each.
- Maintain an overall overview of the pharmacovigilance system, ensuring its proper functioning and continuous compliance.
- Review, update, and maintain the Pharmacovigilance System Master File (PSMF) to ensure accuracy and completeness.
- Stay aware of upcoming audits and inspections and cooperate fully with auditors and inspectors as required.
- Oversee the preparation and submission of safety-related documents to Competent Authorities — including serious adverse reaction reports, Periodic Safety Update Reports (PSURs), and Post-Authorisation Safety Study (PASS) reports — ensuring compliance, even if not directly involved in each report’s preparation.
- Maintain awareness of contractual agreements involving pharmacovigilance tasks and safety data exchange, ensuring these agreements support full compliance with EU PV regulations.
- Ensure timely and accurate responses to any requests for additional information from Competent Authorities regarding the evaluation of a product’s benefit–risk profile.
- Act as the primary contact point for pharmacovigilance inspections or, at minimum, be promptly informed of any inspection activity by the MAH.
- Oversee Risk Management Plan (RMP) activities and ensure these are properly implemented and monitored in accordance with the MAH’s pharmacovigilance strategy.
- A QPPV can be employed by more than one Marketing Authorization Holder (MAH).
In essence, the QPPV serves as the central authority for the company’s pharmacovigilance system, ensuring both strategic oversight and regulatory accountability for patient safety.
Key takeaways
QPPV (Qualified Person for Pharmacovigilance) is a regulatory requirement first introduced in the European Union.
The LPPV (Local Person for Pharmacovigilance) serves a similar role at the national or regional level.
There is no fixed number of years of experience required to become a QPPV.
The QPPV must be residing and operating within the EEA.
The LPPV complements the QPPV by managing country-specific PV operations
Struggling to Maintain Your PSMF?
Looking for a reliable local expert to maintain your PSMF and PV registers? We’re here to support you every step of the way.
Conclusion
The roles of QPPV and LPPV form the cornerstone of a compliant and effective pharmacovigilance system. Together, they ensure that medicinal products remain safe throughout their lifecycle — from monitoring adverse reactions to maintaining transparent communication with regulatory authorities.
While the QPPV provides strategic, system-wide oversight and regulatory accountability at the global or EEA level, the LPPV ensures that local pharmacovigilance operations adhere to country-specific regulations and reporting requirements.
In an evolving global regulatory landscape, these roles are more than just compliance necessities — they are vital functions that uphold public health, patient trust, and corporate responsibility. A well-supported and empowered QPPV, complemented by effective LPPVs, represents a company’s true commitment to drug safety excellence.
Leave a Reply