• Sustainability
  • DE&I
  • Pandemic
  • Finance
  • Legal
  • Technology
  • Regulatory
  • Global
  • Pricing
  • Strategy
  • R&D/Clinical Trials
  • Opinion
  • Executive Roundtable
  • Sales & Marketing
  • Executive Profiles
  • Leadership
  • Market Access
  • Patient Engagement
  • Supply Chain
  • Industry Trends

Doing More With Less: How Automation is Reshaping Drug Safety


Better technology is redefining pharmacovigilance as it expands beyond its traditional compliance focus to become a key business differentiator.

Sharmila Sabaratnam

Sharmila Sabaratnam

Over the past few years, pharmacovigilance caseloads have been rising as more adverse events are reported. At the same time, the number of drug safety regulations and diverse regional requirements is increasing. Both factors challenge pharmacovigilance teams, which still use time-consuming manual processes and multiple siloed software applications to gather, report, and analyze safety data.

In response, more companies have been adopting cloud-based systems to automate and simplify drug safety management processes. Many are also outsourcing pharmacovigilance activities to specialized CROs and service providers, a market that is expected to grow by nearly 15% per year through 2030.1

More CROs and service providers are streamlining drug safety management, enabling effective collaboration with clients worldwide, and tailoring programs to match each company’s strategy, processes, and preferences. Biomapas, a European CRO that offers safety, clinical, and regulatory services, recently replaced a traditional safety database that had become difficult to maintain and upgrade with a cloud-based solution that offers real-time data access and improved security.

The new system has enhanced flexibility and control, says Martijn van de Leur, the company’s head of global pharmacovigilance. He sees continued improvements in technology as essential to patient safety at a time when many sponsors must track and report on larger volumes of drug safety data than ever before yet continue to rely on manual processes and spreadsheet trackers.

Harmonization Without Standardization

While global regulators endorse harmonization, the day-to-day reality for pharma companies is significantly different, as pharmacovigilance regulations in one region are often adopted by other regions and countries, each with slightly different nuances. One example is the Pharmacovigilance System Master File (PSMF), a set of documents that provide comprehensive detail of a company’s drug safety practices. Companies that want to sell drug products in the EU must provide a PSMF to regulators, which has become a prerequisite for selling into other markets. As a result, some Big Pharma companies must manage a PSMF or equivalent documentation in more than 60 countries.

“Maintaining one PSMF already requires a great deal of effort, but now companies need to do that for multiple regions, each with slightly different requirements, and managing this complexity has become a struggle,” says van de Leur. Manual work processes only add to the challenges, especially when the impact of adverse event tracking efforts is factored in. “Each year, people report more adverse events. Depending on manual labor and a sea of spreadsheet trackers isn’t sustainable in the long run. It's already unmanageable for some companies,” he comments.

Even some modern safety tools still require additional offline workflows. For pharmacovigilance, this can weaken the chain of custody. “If an adverse event is reported anywhere in the world, a human being at that location must type something on a form and send it by email. Ideally, they should be able to type the information into a mobile app so that data can flow directly into the safety database,” says van de Leur. The industry may be far from this point, but focusing on real-time data and making it accessible to the right people at the right time represents the first stage in improving drug safety processes.

Cloud-based solutions enable companies to outsource maintenance, upgrades, and updates, freeing staff from system management activities. Biomapas uses a safety database that offers an intuitive user interface and features that were designed to reduce data entry errors. It also provides granular security control and administrative flexibility. These improvements have allowed the company to offer its customers different levels of collaboration. Some clients wish to be directly involved in every pharmacovigilance workflow and to have access to all data. In contrast, others prefer to assign part or most of the work to their outsourcing partner and only have oversight.

With a cloud-based pharmacovigilance application, the service provider and client can decide together on the best approach. Sponsors can access their data in real-time, even though the service provider is entering and managing it, knowing that the entire process takes place in a secure environment.

Flexible Security Enables More Patient Focus and Cross-functional Collaboration

Roles within pharmacovigilance are demanding; technology has the potential to relieve specialists with master’s degrees in life sciences from manual drudgery to focusing on science and patients. Even if the routine application of artificial intelligence (AI) and machine learning in drug safety is still a few years away, there is a significant opportunity for automation with algorithms that can increase productivity and efficiency, and improve data quality, says van de Leur. At the same time, he says that drug safety specialists will need to receive more training in data analytics and other areas that were not part of a traditional curriculum.

Technology could also play a major part in helping the drug industry achieve its goal of making patient safety a shared responsibility across all corporate functions. Improved real-time data access, better reporting capabilities, and the ability to share the data required to ensure patient safety—including safety data coming from clinical or quality systems—will be essential in driving collaborative pharmacovigilance.

In the past, pharmacovigilance was isolated from other departments, van de Leur says, but patient safety is critical to a number of important decisions within the typical drug company. “If we can bring a greater connection to pharmacovigilance and increase its visibility to decision makers from other departments–for example, with easy-to-understand dashboards and overviews–cross-functional collaboration can only increase.”

Better cross-functional connection also fits in with one of the key goals for patient safety that the World Health Organization has set for 2022, with its motto of “medication without harm.” The organization has challenged companies to improve how they engage in patient safety-related work with key stakeholders within and outside the company. Better data access and greater collaboration are crucial to achieving this goal and ensuring that information gets to the right decision-makers at the right time and with consistent quality.

Looking ahead, this capability will offer sponsors a distinct competitive advantage. But it will also permit CROs and service providers to differentiate their offerings by providing clients a customized view of real-time data and processes, with different levels of direct involvement in the pharmacovigilance processes. Technology advancement, automation, and fundamental improvements in how data are shared will all be key to proactive pharmacovigilance. These advances will enable safety professionals to focus on patients and advancing the science of drug safety rather than on administrative tasks and IT issues. For service providers, they will continue to enable better partnership, collaboration, and trust.


  1. Allied Market Research Press Release, “Pharmacovigilance Outsourcing Market Size to Reach $9.65 Billion Globally by 2030,” PRNewswire, August 25, 2021.
Related Videos
Ashley Gaines