How automation increases efficiency and accuracy of local PV monitoring and KPI tracking

For busy safety teams, minimizing the manual tracking component of managing local PV activities can significantly improve data quality and consistency which, in turn, enhances overall audit-readiness and compliance. Implementing secure global systems and processes can usher in a new level of centralized coordination, coupled with the country-specific adaptability and agility needed for optimal management across geographies. 

Crucially, the benefits of automation are not simply tactical but strategic. Streamlined technology solutions for managing local PV activities allow instant data and quality checking, improving visibility of compliance benchmarks and offering valuable trend insights to inform resource-planning and management decision-making. Freeing safety teams from burdensome manual effort allows a much-needed refocus on business-critical safety strategies and value-added activities, plus further aligns companies with the industry shift towards patient-centric PV and a proactive approach to meeting regulatory obligations.

Results like these are not an accident, but are produced by a thoughtful approach to digital innovation around four core principles:

1. Discussions about digital innovation are often driven by hype – but hype is not a strategy
2. Digital innovation is not about technology, it’s a human-focused transformation process
3. The desired outcome should drive innovation – not the other way around
4. Successful outcomes require broad and deep understanding of your business

By combining deep safety expertise with innovation encompassing proven and emerging digital technologies, companies can obtain the right balance of pragmatic innovation with measurable outcomes. Key examples of this methodology at work for local PV operations include:

With confidentiality and data protection assured through access on a per-role and per-country basis, the safety team can automatically aggregate and calculate KPI data and SLA metrics – eliminating for the need for manual tracking and maintaining complex spreadsheets and consolidation formulas. 

Automated trackers are instantly available for ICSR activity, literature surveillance and PV intelligence, supported by volumetric reporting viewable by time period and country, headline metrics, counts over time, projections and top ‘n’. This holistic tracking enables the activation of new features such as automated invoice creation, trend analysis and capacity planning plus advanced customer reporting.

For quality reporting, the customer can now also configure processing SLAs (for example, reporting ICSRs to the customer in a set number of days) and highlight key areas of concerns on a country basis, including ICSR submission delays and performance trends over time. 

To facilitate KPI tracking, the company has gained a clear and consistent overview of the crucial metrics per activity – such as the time taken to report ICSRs to the Marketing Authorization Holder; when PV Intelligence results and impact assessments have been sent; and whether local literature has been screened on time. KPIs can be easily analyzed per country, and compliance reports for each activity can be readily generated on a per country basis for management review.

A further, crucial capability for the customer’s safety teams is the ability to easily extract custom tracking reports for cross-checking and reconciliation with internal safety databases.

While close monitoring of local pharmacovigilance activities is essential for compliance in today’s complex and diverse regulatory environment, it demands significant resources that are increasingly unsustainable – and unscalable – for many biopharmaceutical businesses. To address this growing challenge, organizations are turning to tech-forward outsourcing partners and validated tracking systems that can streamline operations. 

By delivering centralized coordination and visibility, with full flexibility for specific local needs, automated solutions are proving to be effective for improving efficiency and accuracy of PV operations.