Zahra Majed
Pharmacist, University of Bologna, Italy
Can human factors science help pharmacovigilance deliver on its promise? Eight guiding principles offer a shared framework for turning safety signals into real-world protection.
A key purpose of pharmacovigilance (PV) is not only to identify medicine-related risks, but to ensure that safety knowledge results in effective protection. Today’s PV systems can collect more reports, analyse more data, and communicate safety concerns faster than ever before. These advances do not, however, automatically translate to better patient protection. A signal may be assessed and a risk-minimisation measure put in place, yet if this information is difficult to understand or use, responsibility for action is unclear, or its real-world impact hard to evaluate, preventable harm continues. The use of artificial intelligence in PV may help address such issues, yet concerns exist regarding the adequacy of human oversight for its use in PV methods and processes. The result is a performance gap between safety knowledge and actual patient protection.
Why does this gap exist? When the authors and other colleagues examined other safety-critical sectors, what is notable in PV is the failure to systematically apply human factors science, which refers to how people interact with tasks, tools, organisations, and real-life working conditions. We need to recognise that pharmacovigilance is a complex socio-technical safety system whereby human performance depends on how people, technologies, organisations, culture, governance, and local capacity interact and collaborate.
This perspective may help explain why the same gaps can appear for different pharmacovigilance settings. In resource-limited systems, the challenge may be insufficient staffing, training or infrastructure. For more advanced, data-rich systems, challenges may differ: fragmented platforms, duplicated work, information overload, or unclear responsibility. Although WHO has released a global Smart PV strategy, each national system will differ as it must meet its own public health needs adapted to local societal settings. A shared understanding of what effective human performance looks like and how it may improve the use of medicines and devices is needed to help countries adapt and apply the strategy effectively.
Other complex safety-critical sectors use guiding principles for organisations that want to be part of the system. As comparable guiding principles do not exist for pharmacovigilance, we have developed eight interconnected human-centred guiding principles to help bridge this performance gap. These are:
Inclusive and representative safety knowledge
A fair, trust-based learning and safety culture
Setting people up for success
Strategic risk prioritisation
Meaningful measurement, feedback, and learning
Trusted, transparent, and action-oriented risk communication
Integrated accountability, coordination, and governance
Adaptive and resilient implementation for sustainable safety improvement.
The principles are interconnected because safety information passes through people, decisions, and organisations. Missing voices leave the evidence incomplete. Fear can suppress reporting. Poor tools, unclear priorities, or divided responsibility can interrupt action. Without measurement and feedback, the system cannot know whether its response changed practice or reduced harm. By making these failure points visible, the framework shows where improvements may be made.
Patients and caregivers can ask whether their experiences are represented, and safety advice is realistic. Healthcare professionals can examine whether processes fit everyday work. Companies, national centres, and regulators can assess prioritisation, coordination, and the outcomes of risk-minimisation measures. For researchers, the framework turns human performance concerns into study questions: Was an intervention adopted and usable? Was it understood? Did coordination improve? Did safer action follow? Evaluation can therefore move from counting activities to examining their safety value.
We believe these human-centred guiding principles can help translate the WHO Global Smart Pharmacovigilance Strategy into practice by providing a shared performance logic that can be adapted to local needs, providing global harmonisation without requiring every system to be identical. We have outlined a pathway to test and adapt these principles. In summary, a system owner first examines how safety work happens, identifies a priority gap, and selects the relevant principle.
Together, the principles form a human-centred framework for connecting regulation, scientific judgement, people, and infrastructure, rather than replacing them. Of course, the framework still requires testing in different settings, but it provides a clear basis for deciding where that testing should begin and how meaningful improvement should be judged. We believe human-centred guiding principles will help pharmacovigilance systems turn safety information into shared understanding and timely, coordinated action, to improve future decisions and patient protection in real-world practice. We welcome others who are interested in joining us on this journey towards putting humans at the centre of pharmacovigilance.
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Zahra Majed
Pharmacist, University of Bologna, Italy
Brian Edwards
Managing Director, Husoteria Ltd, UK
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