Marketing Authorisation Holders (MAHs) with marketed medicinal or veterinary medicinal products within the European Economic Area (EEA) are obligated by law to establish a Pharmacovigilance (PV) system in order to fulfil their PV obligations for their products.
MAHs operating within the European Union (EU) must designate a suitably Qualified Person for Pharmacovigilance (QPPV) to ensure compliance with the compulsory requirements for ongoing and consistent Pharmacovigilance and Veterinary Pharmacovigilance as mandated by EU regulations.
QPPVs must be residents of an EEA Member State, must be registered in the European Union’s EudraVigilance and EVVet databases, and personally bear legal responsibility for the safety of the MAH’s products.
For the United Kingdom (UK), where a QPPV does not reside in the UK, a Local Person for PV (LPPV) residing in the UK must be appointed.
Click for more information in the EU regulations Medicinal Product Directive (MPD), and Regulation (EC) No 726/2004.
The role of a Qualified Person for Pharmacovigilance (QPPV) encompasses a range of vital functions and duties within a Marketing Authorization Holder’s (MAH) pharmacovigilance framework.
These responsibilities are integral to maintaining product safety, ensuring regulatory compliance, and upholding the quality of the entire system. Key QPPV activities include:
The QPPV is tasked with creating and overseeing the MAH’s pharmacovigilance system, ensuring its proper functioning, and maintaining its integrity.
The QPPV acts as the primary contact point and is available around the clock to provide responses related to safety and benefit-risk evaluations to EU national Competent Authorities and the European Medicines Agency (EMA).
The QPPV is responsible for ensuring that the PSMF remains up-to-date and accurately reflects the current state of the pharmacovigilance system.
The QPPV monitors and oversees the safety profiles of marketed products, including identifying and addressing emerging safety concerns.
The QPPV ensures that all pharmacovigilance activities and the submission of related documents align with GVP and VGVP practices and all other relevant legal requirements.
Acting as a point of contact, the QPPV manages interactions with regulatory authorities during pharmacovigilance audits or inspections.
Detailed records of suspected adverse reactions (AERs) to products are diligently maintained by the QPPV.
The QPPV is responsible for drafting and submitting Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) to national Competent Authorities and/or the EMA.
The QPPV’s pivotal role extends to the establishment and management of the pharmacovigilance system, acting as a central point of contact for regulatory agencies, ensuring compliance with regulations, and overseeing product safety and benefit-risk assessments. Additionally, the QPPV is responsible for maintaining meticulous records and preparing essential reports to uphold pharmaceutical safety standards.
Our team of highly experienced Qualified Persons for Pharmacovigilance (QPPVs) serves as a bridge for seamless communication among all stakeholders within a robust and efficient Quality Management System.
We specialize in creating and maintaining both global and local Pharmacovigilance System Master Files (PSMFs), ensuring that your pharmacovigilance system consistently complies with EU and International regulations, guaranteeing readiness for inspections.
Whether you’re implementing a new pharmacovigilance system or transitioning from an in-house PV department or a previous provider, our experienced team provides comprehensive guidance to navigate all required PV activities and meet QPPV requirements.
Depending on the applicable regulations, we can also offer support at the country level with Local Persons for Pharmacovigilance (LPPV) and Local Safety Officer (LSO) services.
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