Pharmacovigilance for Herbal Products in the Age of AI

Learning Safety Science Where Tradition Meets Technology

Herbal and nutraceutical products are often perceived as “naturally safe,” yet real-world use tells a more complex story. As consumption rises globally, so does the need for robust pharmacovigilance (PV) adapted specifically for botanicals and enhanced by modern AI tools.

This program is designed to train students in next-generation pharmacovigilance, combining classical safety science with AI-driven workflows tailored for herbal and nutraceutical products.

Understanding Herbal ADRs: Where Safety Questions Begin

The journey starts with adverse drug reactions (ADRs) in herbal and nutraceutical products an area often underexplored and underreported.

Students learn to:

• Identify ADRs unique to botanicals and multi-ingredient products
• Classify reactions as expected or unexpected
• Explore real case examples from scientific literature and safety databases

Rather than passively reading reports, interns actively develop hypotheses on why ADRs occur, considering factors such as formulation complexity, bioactive variability, and herb–drug interactions. This sets the scientific foundation for meaningful safety monitoring.

Scientific Prompting: Using AI in Pharmacovigilance

Modern PV is no longer paper-based and neither is this program.

Interns are introduced to AI-assisted pharmacovigilance workflows, where they learn how structured safety data is generated and interpreted. Key focus areas include:

• Individual Case Safety Reports (ICSRs)
• Medical coding using standardized terminologies
• Writing clear, regulator-ready safety narratives

Through scientific prompting, students use AI tools to draft a mock ICSR for a herbal ADR practicing both analytical thinking and precise medical writing. The emphasis is on human-guided AI, not blind automation.

Signal Detection in Herbal Safety: Finding Patterns in the Noise

Herbal pharmacovigilance presents unique challenges: inconsistent reporting, lack of denominator data, and uncertain causality. This section addresses these issues head-on.

Using mock ADR datasets, interns perform:

• Classical signal detection methods such as proportional reporting ratios and reporting odds ratios
• AI-based pattern recognition for early signal identification

Real-world inspired case studies such as hepatotoxicity signals linked to popular botanicals help students understand how safety signals emerge, evolve, and demand further evaluation.

From Signals to Strategy: Risk Assessment & Reporting

Pharmacovigilance only matters if signals lead to action.

In the final phase, students integrate all prior learning into risk assessment and reporting frameworks. They explore:

• Global pharmacovigilance systems across major regulatory regions
• Risk characterization for herbal products
• Designing practical monitoring and mitigation strategies

Each intern prepares a mini pharmacovigilance plan for a herbal product, linking identified signals to real-world risk management decisions. The internship concludes with a concise, professional-grade safety report mirroring industry expectations.

What Students Take Away

By the end of the program, interns are able to:

• Understand and evaluate ADRs in herbal and nutraceutical products
• Draft structured ICSRs using AI-assisted tools
• Apply both traditional and AI-based signal detection methods
• Perform pharmacovigilance risk assessments and write formal reports

More importantly, they gain confidence in navigating a field where regulatory science, data analysis, and AI intersect.

Final Perspective

As herbal products move further into mainstream healthcare, their safety monitoring must evolve just as rapidly. This program equips students with hands-on pharmacovigilance skills, preparing them for careers in drug safety, regulatory affairs, digital health, and AI-enabled life sciences.

It’s not just about monitoring risk it’s about learning how science, safety, and technology work together to protect public health.

Dr Pravin Badhe
Founder and CEO of Swalife Biotech Pvt Ltd India/Ireland