Abstract
Pharmacovigilance has attracted enormous attention over recent decades. At present, the increasing datafication combined with the growing knowledge elicitation capabilities of key technology innovations, present pharmacovigilance with enormous opportunities to improve its effectiveness and widen its scope. With change being a continuous process, for pharmacovigilance this represents an era of “Digital Darwinism”, during which new directions are opening fast and new challenges emerge, as to how the sector adapts in order to draw benefit. Current efforts and initiatives, aimed at addressing existing barriers and at enhancing the practical applications of new science and technology, are fragmented and disjoint, and thus are not adequate to provide an effective response to challenges. This research proposes a new paradigm for collaborative, information-driven innovation in pharmacovigilance and develops a Reference Framework, in order to (a) deepen the collective understanding of how a principled, collaborative and balanced medicines safety data ecosystem can be organised, (b) guide stakeholders towards the optimisation of pharmacovigilance and (c) provide useful reference points for the ongoing research and development process in the field. The Knowledge Discovery Cube (KDC) Framework provides the means for continual analysis, and for managing technology adoption in an informed and intentional manner. A variety of sources informed the research work. The resulting deliberations draw on the findings and conclusions of scholarly research, guidelines, policy documents and reports, and other resources from within and outside the field of health and life sciences, as well as on relevant theories. The developed framework was operationalised and validated in the context of vaccine safety monitoring.