Blogs

Evolving the System Validation Plan (SVP) for AI-Enabled Pharmacovigilance Systems For years the validation playbook in pharmacovigilance barely changed, and for good reason — it worked. You wrote a User Requirement Specification, the team built the code against it, you put together a validation plan, ran your IQ, OQ and PQ, signed off the Validation Summary Report, and issued the release notice. Clean, linear, defensible. An auditor could trace any output back through the system to a requirement, and you could prove, with evidence, that the system did exactly what it was specified to do....

Artificial intelligence is rapidly modernising pharmacovigilance (PV). It now offers powerful capabilities for processing Individual Case Safety Reports (ICSRs), detecting safety signals, and predicting adverse drug reactions. However, as AI systems become more sophisticated, many rely on complex “black-box” models. These models can produce highly accurate results, but their internal reasoning is often difficult for humans to interpret. This raises an important question: How can PV professionals and regulators trust decisions they cannot clearly understand?...

Pharmacovigilance has long sat at the heart of patient safety, traditionally relying on structured processes and conservative risk management to detect and prevent adverse drug reactions. Today, Artificial Intelligence is fundamentally transforming PV operations-from automated case intake and triage using Natural Language Processing to machine learning algorithms identifying patterns across massive safety datasets. However, introducing dynamic, learning AI systems into a highly regulated environment raises a critical challenge: How do we govern and validate these systems while maintaining compliance and patient protection?...

Whether you are in a big pharma company, an emerging biotech, or a CRO, the reality is the same: we all rely on vendors. But simply hiring a vendor and hoping for the best doesn’t cut it anymore. Today, having a rock-solid oversight process and governance model isn’t just “nice to have” - it is survival. You might be asking, “Why the sudden urgency?” The short answer is that the regulators have drawn a line in the sand....

For a significant part of my career, I thrived as an Individual Contributor. I had the opportunity to lead projects, make technical decisions, and managed project teams, but I eventually realized that managing a project is vastly different from leading people. Growing up, I was fortunate to be surrounded by exceptional leaders. Speaking with them didn’’’t just inform me; it inspired me. I aspired to be transformational, someone who motivates people to achieve both personal and organizational heights rather than a transactional manager who simply tracks tasks and manages output....