A digital journey to better local PV oversight and decision-making

Literature screening at the local level has long been a highly fragmented and manual process. Local PV teams must search in-country journals and identify relevant safety information, carry out quality checks, and conduct literature reconciliation and reporting. Often, each country has its own processes for managing local literature screening.  

Digital solutions enable a centralized approach, applying the same rules across the world, regardless of the language of the documents or local specifications, while still supporting locally required nuances and practices. For pharmaceutical companies, the value lies in stronger safety coverage, reduced risk of missed information, shorter cycle times, and clearer evidence of how the literature screening was performed.

What a digital approach enables is a globally controlled and harmonized process for collecting data from all these local journals, creating greater consistency across countries. 

One of the core objectives for biopharmaceutical companies is to centralize their PV processes as much as possible while maintaining the same level of quality and adherence to local requirements. 

This is especially important for the qualified person for pharmacovigilance (QPPV), who needs sufficient oversight of the pharmacovigilance system and must be able to access reliable information quickly.¹ Digital capabilities can support the QPPV by providing a consolidated view of PV activities, open actions, metrics, deviations, literature screening status, local requirements, partner responsibilities, and inspection-relevant evidence. Instead of relying on manual updates, spreadsheets, or country-by-country follow-up, the QPPV can use structured dashboards and workflows to identify issues earlier, prioritize risk-based follow-up, and demonstrate oversight when challenged by auditors or regulators.

It also provides them with up-to-date pharmacovigilance intelligence of all global regulations and local interpretations by PV affiliates. A digital oversight and communications capability lets PV leaders raise queries about upcoming regulations and see an impact analysis of how these changes would impact their existing processes – all within a single validated, secure environment. It also makes it easier to generate key performance indicators from a centralized dashboard to have visibility into – and carry out quality checks of – the local case processing workflow. In general, this will allow PV leaders to move from reactive issue management to more proactive oversight.

One of the complexities biopharmaceutical companies face with managing their global and local PV responsibilities is having clear oversight of their various contracts and partnerships with local distributors and other partners. Currently, many companies that operate globally use multiple vendors in different countries, each of which collects and captures data on local spreadsheets. As such, it is labor-intensive to ensure visibility into what is happening in those different territories and demonstrate compliance with regulations and partner agreements. 

Digitalizing this oversight helps companies manage those contracts and have clarity into the responsibilities handled by those various partners; for example, how are they collecting adverse events and to whom are these being reported? 

Digitalization cannot and should not remove the local dimension of pharmacovigilance. Instead, it should make local expertise more visible, better connected, and easier to apply consistently. 

What digital tools change is the way in which companies manage their PV compliance obligations. It allows them to adopt an end-to-end approach with key information available to all PV stakeholders across the organization. For instance, it removes the manual complexities of local literature screening, enables local case processing reconciliation and reporting, and allows companies to stay on top of PV intelligence region by region. In so doing, digital tools equip PV teams with validated data to help them make the right decisions, demonstrate compliance, and quickly provide the evidence auditors are looking for. 

As product portfolios expand and companies enter new markets, digital capabilities can reduce the incremental burden of adding countries, sources, partners, or requirements. The value for pharmaceutical companies comes from combining the reach and consistency of a global operating model with the insight of local specialists. This balanced model also enables companies to scale, while helping ensure this does not come at the expense of regulatory accuracy or inspection readiness.