Be part of a vital global dialogue on how we integrate emerging technologies into medicine — safely, ethically, and effectively.

The Council for International Organisations of Medical Sciences (CIOMS) has just released a draft report on Artificial Intelligence (AI) in Pharmacovigilance (PV) — and it's now open for public comment until Friday, 6th June 2025.

Crafted by CIOMS Working Group XIV, the report offers practical guidance for evaluating the role of AI in pharmacovigilance (PV) — highlighting risks, regulatory expectations, and the need for human oversight. But whilst the potential of AI is explored, the message remains clear: responsible automation — proven, explainable, and auditable — remains the gold standard for safety-critical functions today.

What Does the CIOMS Draft on AI in Pharmacovigilance Cover?

This report covers:

• Risk-based strategies for integrating AI in PV systems
• AI model validation and performance monitoring
• Transparency and traceability in AI and LLM use
• Human-in-the-loop system design
• Ethics, data security, and responsible generative AI use
• Addressing bias and ensuring fairness
• Governance, accountability, and regulatory compliance
• Practical applications in triage, signal detection, and ADR prediction

Why This Matters: Automation Today, AI Tomorrow

If you're a pharmacovigilance professional, regulator, AI developer, or pharmaceutical stakeholder, this is your moment to influence how emerging technologies shape drug safety worldwide.

Whilst enthusiasm around AI continues to build, it’s essential to focus on what’s already working. Validated automation — not speculative AI — remains the most reliable, compliant, and effective approach for pharmacovigilance today.

Here’s why automation leads:

• Delivers consistent accuracy and traceable processes
• Ensures audit-readiness and regulatory compliance
• Supports scalable, human-supervised workflows

AI may have a role to play in the future — but its adoption must be careful, risk-aware, and firmly rooted in human oversight.

📄 Read the full draft and submit your feedback here

📅 Deadline: Friday, 6th June 2025

Need Clarity on AI vs Automation in PV? Let PharSafer Help

At PharSafer, we help organisations adopt automation with precision and compliance.

Our focus is on tools that are validated, explainable, and seamlessly integrated into regulatory frameworks, including:

• Regulatory and operational suitability assessments
• Human-in-the-loop workflow design
• Compliance-aligned process updates
• Validation support and inspection preparation

In short, we believe in automation now. AI when it’s ready.

Let’s build safer PV systems together.

If you have any questions or require further guidance, please contact us directly: enquiries@pharsafer.com 📧