This is our story of streamlining and scaling up pharmacovigilance case processing for a biotechnology major by implementing a tailored SaaS solution for accurate, expedited and cost-effective compliance.

As we know…

In the wake of ever-evolving regulations and accelerated product development, the pharmaceutical industry is pressured to manage patient safety more efficiently. Companies must ensure compliance with nuanced, country-specific safety regulations and the timely submission of safety events. Navigating these mandates can be overwhelming, marked by substantial resource demands and a challenging alignment with value-creation objectives.

The manual orchestration of these tasks is cumbersome and error-prone, particularly accentuated in the context of multi-product triaging. As the volume of safety events surges across various product categories, organizations are increasingly turning to automated, scalable solutions. Such systems can efficiently process cases from both structured and unstructured data sources, enhancing productivity, accuracy and compliance while reducing costs.

The pharmacovigilance challenge for our client, a prominent biotechnology firm, was…

Multi-faceted: In maintaining compliance with regulatory requirements across its vast product portfolio, there was reliance on manual, labor-intensive processes.

These antiquated methods were prone to high error rates and severely compromised scalability. While fluctuations in case volumes exacerbated the operational strain, the prospect of augmenting the workforce during peak periods was improbable. This led to unavoidable delays in reporting adverse events to regulatory authorities.

The dependence on outdated tools such as Excel sheets – for critical tasks such as managing search criteria, downloading schedules, performing manual case reviews and ensuring audit readiness – added to the workflow complexity.

Stepping in as a digital transformation partner…

WNS undertook a thorough process discovery exercise to gain insights into the client's workflows and technology ecosystem. Our team of experts closely collaborated with stakeholders from the pharmacovigilance and compliance departments to identify pain points and devise a tailored solution.

Leveraging our expertise in process optimization and digitalization, we proposed implementing a cutting-edge, Software-as-a-Service (SaaS) solution designed to automate the end-to-end process for handling adverse events while adhering to regulatory standards and boosting operational performance.

Key elements of the solution included:

By automating case processing, WNS’ SaaS solution…

Enabled the holistic digital transformation of the client’s pharmacovigilance operations. This significantly reduced processing timelines, enhanced data accuracy, fortified regulatory compliance and freed the client (from operational quagmires) to focus on value-added activities.

Tangible outcomes included




cost savings owing to process automation

More than



reduction in case-handling time

A scaled-up system capable of handling



cases daily



data accuracy

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