Pharmacovigilance (PV for Herbal & AI Tools)

This internship trains students in modern pharmacovigilance (PV), focusing on herbal/nutraceutical products and the integration of AI tools. Over four sections, students will learn ADR collection, case report writing, signal detection, and risk assessment.

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ADR Literature & Hypothesis
Students study adverse drug reactions (ADRs) specific to herbal and nutraceutical products. They learn to classify ADRs as expected or unexpected and collect case examples from literature databases. The section ends with hypothesis development on ADR monitoring.

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Scientific Prompting for PV
Interns are introduced to AI-driven pharmacovigilance workflows. They learn about Individual Case Safety Reports (ICSRs), MedDRA coding, and narrative generation. Using AI prompting, they draft a mock ICSR for a herbal ADR, practicing both coding and narrative writing.

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Week 3 – PV for Herbal & AI Tools
This section highlights the challenges of ADR reporting in herbal/nutraceuticals, such as underreporting and causality gaps. Students use mock ADR datasets to perform signal detection with both traditional methods (PRR, ROR) and AI-based tools. Case studies like turmeric hepatotoxicity are explored.

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Week 4 – Risk Assessment & Reporting
The final section integrates all concepts into compliance and reporting. Students study global PV systems (India, US, EU), perform risk assessments, and draft mini PV plans for herbal products. They learn how to link signals to risks and propose monitoring strategies, concluding with a 3–5 page mini report.

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Outcome for Students
By completing this internship, students will:

• Understand ADRs in herbal/nutraceuticals.

• Draft ICSRs with AI-assisted tools.

• Apply signal detection methods to herbal ADR datasets.

• Conduct PV risk assessments and prepare professional reports.

This program provides interns with hands-on pharmacovigilance skills, bridging traditional safety monitoring with AI-enhanced methods for herbal and digital health products.