Meet your QPPV obligation with a named, accountable expert
Every marketing authorization holder in the European Union must name a qualified person responsible for pharmacovigilance. The role carries personal accountability for the safety of every product in the portfolio, and regulators treat it as the point where oversight either works or fails.
Cencora provides that person. Our EU QPPVs sit within the European Union and European Economic Area, hold life science, pharmacy, medical or veterinary qualifications, and are backed by a deputy and a call system that keeps the role reachable at any hour.
Cencora provides that person. Our EU QPPVs sit within the European Union and European Economic Area, hold life science, pharmacy, medical or veterinary qualifications, and are backed by a deputy and a call system that keeps the role reachable at any hour.
Close the oversight gaps inspectors look for first
Inspection findings against the QPPV rarely concern the person's competence. They concern what the person could not see: activities begun without them, data they could not reach, files that had drifted out of date.
Oversight without visibility
New programs, acquisitions and vendor changes begin without the QPPV being told, so accountability sits with someone who cannot see the activity.
Restricted data access
Access to the safety database and risk documentation is limited or undocumented, which delays signal detection and shows up directly in findings.
A drifting master file
The pharmacovigilance system master file falls behind the system it describes, and inspectors read the gap as evidence of weak control.
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Full EU QPPV cover, including deputy and out-of-hours reach
You get a named EU QPPV who takes responsibility for your pharmacovigilance system, a nominated deputy, and back-up arrangements that keep the role available at any hour.
The same person maintains your pharmacovigilance system master file, oversees your risk management plans and the risk minimization measures inside them, and acts as your standing point of contact for regulators.
The same person maintains your pharmacovigilance system master file, oversees your risk management plans and the risk minimization measures inside them, and acts as your standing point of contact for regulators.
What we offer
EU QPPV appointment
A named qualified person located in the European Union or European Economic Area, appointed to your pharmacovigilance system.
Deputy and back-up cover
A nominated deputy plus call-system arrangements so the role stays reachable by regulators at any hour of the year.
U.K. QPPV cover
The same specialists can hold the U.K. QPPV role where your portfolio requires one alongside the European appointment.
Master file maintenance
Ownership of your pharmacovigilance system master file, kept current against the system it describes and ready for inspection.
Risk management oversight
Review and oversight of risk management plans, the risk minimization measures inside them, and the commitments attached to your authorizations.
Inspection readiness support
Governance frameworks, documented delegation, compliance checklists and audit templates that make QPPV oversight visible to an inspector.
Expert insight
The QPPV must have an overview of all PV activities, processes, and safety profiles of each product and always be available to the competent authorities.
— Monica Buchberger, Ph.D., and Stephen Sun, MD, MPH
Bringing a product to market in the EU: PV considerations for non-EU companies
PharmaLex is now Cencora
Qualified person for pharmacovigilance (QPPV) is part of our Commercialization support capability. Same team, same expertise, now with greater reach.
Need more information about how we can support you with QPPV?
Our team of experts is here to assist you. Whether you have questions or need more detailed information, don’t hesitate to get in touch. We’re dedicated to providing the support you need.