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Pharmacovigilance > Intermediate
Practical Generative AI in Pharmacovigilance
A hands-on course on applying generative AI throughout the pharmacovigilance lifecycle — from ICSR processing and signal detection to aggregate reporting and regulatory submissions. Learn how to use AI tools safely within PV compliance boundaries, including prompt design, validation, and human oversight requirements for drug safety teams.
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What you'll learn
- A hands-on course on applying generative AI throughout the pharmacovigilance lifecycle — from ICSR processing and signal detection to aggregate reporting and regulatory submissions
Course content
Welcome
Audience and Outcomes
Manual to RPA to AI
Why Generative AI Turning Point
AI Across PV Lifecycle
Skills in AI Era
AI Ml NLP LLMs Explained Simply
Supervised Unsupervised Transfer Learning
Classification Extraction Summarization in PV
Rag Small Language Models Agentic AI Basics
ChatGPT Claude Gemini Copilot in PV Context
Prompt Engineering for PV Tasks
Building Reliable Prompts for Regulated Work
Common Prompting Mistakes and Output Risks
AI for Case Intake and Triage
AI for Narrative Drafting and Case Summaries
AI for Literature Screening and Signal Support
AI for Workflow Automation and Productivity
GxP Mindset for AI in PV
Validation Approaches for AI Enabled PV Use Cases
Audit Trail Documentation and Defensibility
How to Defend AI Use to Auditors and Inspectors
Data Privacy and Confidentiality in AI Workflows
Bias Hallucination and Reliability Risks
Human in the Loop and Human on the Loop Models
Ethical Use of AI in Pharmacovigilance
What AI Enabled PV Platforms Are Trying to Do
Oracle Iqvia Arisglobal Rxlogix What to Evaluate
Vendor Questions Every PV Team Should Ask
Build vs Buy vs Hybrid AI Strategy
FDA EMA and Global Direction on AI
What the EMA Reflection Paper Means in Practice
AI Guidance Trends Across the Medicines Lifecycle
Cioms and Industry Thinking on AI in PV
From NLP and Ml to Generative and Agentic AI
The Future Intelligent PV Department
Digital Workforce Copilots and Automation Layers
What Will Still Need Human Judgment
How to Prioritize the Right Use Cases
Pilot Design Metrics and Governance
Building a Practical AI Roadmap for a PV Function
Final Wrap up and Next Career Steps
Requirements
- No prior experience required unless stated in the lessons.
Description
A hands-on course on applying generative AI throughout the pharmacovigilance lifecycle — from ICSR processing and signal detection to aggregate reporting and regulatory submissions. Learn how to use AI tools safely within PV compliance boundaries, including prompt design, validation, and human oversight requirements for drug safety teams.
This course is designed for:
- SafeMeds Academy learners
- Life-science professionals building practical confidence
Instructor
SafeMeds Academy
Life-science curriculum specialist
Practical training for pharma, biotech, CRO, regulatory, clinical, PV, market access, medical writing, data, and AI-enabled teams across the globe.
How to earn your certificate
- Watch the lessons. Each lesson is marked complete automatically once you have watched 90% of its video — there is no button to click.
- Reach 100%. When all 42 lessons are complete, the final quiz unlocks in your course player and dashboard.
- Pass the final quiz. 20 multiple-choice questions, 70% to pass (14/20), with unlimited retries.
- Get your certificate. It is issued to your account automatically, emailed to you, and verifiable online.
Frequently asked questions
Student reviews1 review
DelixJun 13, 2026