Every marketing authorisation holder with veterinary products needs a qualified person responsible for pharmacovigilance. The role is easy to fill badly: a name entered on a form, attached to a person with a full-time job elsewhere and no real visibility of the safety data. Regulation (EU) 2019/6 expects something considerably more substantial, and inspections test the difference.
What the role requires
The qualified person must be a suitably qualified professional with expertise in veterinary pharmacovigilance and a comprehensive understanding of the regulatory framework. Two elements of that are worth separating. Expertise in veterinary pharmacovigilance is not the same as expertise in human pharmacovigilance; the data sources, the reporting populations and the adverse event landscape all differ. And understanding the regulatory framework means knowing what the regulation actually obliges the holder to do, not just how to process a case.
Responsibility for signal management
The qualified person is responsible for overseeing signal management, ensuring that possible emerging risks are identified and acted on promptly. Under Regulation (EU) 2019/6, marketing authorisation holders must carry out signal management taking into account all relevant pharmacovigilance data they can reasonably be expected to be aware of, including sales data. A qualified person who cannot see sales data, or who receives case information weeks after intake, cannot discharge that responsibility however well qualified they are.
What makes the role work
- Authority. The ability to require action, escalate to senior management and, if necessary, stop something. A qualified person who can only recommend is not performing the role.
- Access. Direct visibility of case intake, the safety database, sales and exposure data, literature monitoring and regulatory correspondence.
- Time. Realistic capacity proportionate to the portfolio. Inspectors do ask how many hours the role receives.
- Deputisation. A named back-up with equivalent access, so the system does not depend on one person being reachable.
- Documentation. The role, its reporting lines and its delegations described accurately in the pharmacovigilance system master file.
Outsourcing the function
Many companies, particularly those without a large local presence, contract the qualified person role to a service provider. This is entirely legitimate and often produces a stronger system than an internal appointment made for convenience. But the marketing authorisation holder remains accountable for the pharmacovigilance system. The contract has to define responsibilities precisely, the arrangement must appear in the master file, and the holder needs a genuine oversight mechanism rather than an annual invoice.
The inspection question
The question an inspector is really asking is whether the qualified person knows the products, knows the safety profile and knows what has happened recently. A person who has to look things up from scratch reveals the answer regardless of what the documentation says.
How PQRA helps
PQRA provides qualified person services for veterinary medicinal products, including the role itself, deputisation, and support to companies appointing internally. We assess whether an existing arrangement would withstand inspection, build the access and escalation routes the role depends on, and document it properly in the pharmacovigilance system master file.
To discuss veterinary qualified person arrangements, contact PQRA.
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