Building Pharmacovigilance That Lasts with Robust Data Governance

The volume of Individual Case Safety Reports (ICSRs) is growing at an unprecedented scale, and regulations continue to evolve. For pharmaceutical companies, the challenge is clear: ensure patient safety, maintain compliance, and scale operations without spiraling costs.

“Think of safety data as the building blocks of a house. You want to ensure a solid foundation; you want to construct a safe and stable building. Without a solid foundation of your safety data, over time you risk cracks appearing, repairs becoming costly, and the whole structure being at risk,” says Majka Johansson.

Data governance is that foundation. If it is not in place, you cannot build advanced capabilities on top of it, including AI, automation, and future-ready digital tools.

When implemented effectively, robust data governance delivers three essential advantages for pharmacovigilance:

1. Quality assurance

Well-defined processes, compliance with standards such as E2B (R3), and ongoing data monitoring ensure accuracy, build trust, and reduce the risk of penalties.

2. Streamlined case handling

Standardized processes, AI-assisted reviews, and predefined templates reduce manual workloads and lower the risk of human error.

3. Competitive advantage

Transparent, well-controlled data enables faster safety-signal detection, product improvements, and a stronger market position.

Its importance becomes even greater during cloud migrations or when integrating legacy systems with newly acquired company data. Without governance, inconsistencies, errors, and compliance risks quickly multiply.

By embedding governance from the first patient interaction, companies ensure data reliability, reduce manual intervention, and support better patient outcomes.

“In today’s environment of digital transformation, strong data governance is not just an advantage - it is a necessity for building lasting, resilient pharmacovigilance systems,” Majka Johansson concludes.

NNIT will be at World Drug Safety 2025 in Amsterdam. Visit our booth to learn more about how to lay the right foundation for your pharmacovigilance ‘house,’ preparing it for AI, automation, and whatever comes next.