PHARMACOVIGILANCE IN AI ENVIRONMENT - Qtech-Sol offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Analytics and Reporting
 
Duration:
8 Weeks / 140 Hours
 
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Pharmacovigilance in AI Environment

Introduction –PV in the AI Era

Pharmacovigilance (PV) is evolving rapidly with the integration of Artificial Intelligence (AI) and Machine Learning (ML). Traditional PV workflows such as case intake, coding, signal detection, and reporting are now being enhanced by AI to deliver greater speed, accuracy, and compliance.
The PVAI program prepares learners to understand and apply AI technologies in pharmacovigilance operations. It blends PV regulatory foundations with AI-driven innovations, enabling professionals to transition into next-generation drug safety roles.

Course Name :  Pharmacovigilance in AI Environment
Course Code :  PVAI
Experience Level :  Intermediate to Advanced
Qualification :  Bachelor’s / Master’s in Life Sciences, Pharmacy, Nursing, Medicine, Public Health, or Data Science
Student Category :  Drug Safety Associates, PV Specialists, Medical Reviewers, Clinical Data Managers, AI/ML Enthusiasts entering PV

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 8 weeks (140 hours)
  2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).
Key Learning Objectives

   By completing this program, learners will:

  2. Understand how AI integrates into PV workflows across clinical trials and post-marketing.
  3. Explore automation in ICSR case intake, triage, and follow-up.
  4. Learn how NLP supports narrative writing and literature monitoring.
  5. Gain knowledge of AI-assisted MedDRA/WHO-DD coding.
  6. Apply AI tools for signal detection, benefit–risk assessment, and risk management.
  7. Examine AI-enabled PV databases such as Argus, ArisG, and Veeva Safety.
  8. Learn compliance requirements (ICH-E2B, FDA, EMA, GDPR, HIPAA) for AI-driven PV.
  9. Review case studies of AI-enabled pharmacovigilance in pharma and CROs.
Who Should Take This Course
  1. Drug Safety Associates (DSAs) & PV Specialists preparing for AI-enhanced roles.
  2. Medical Reviewers & Scientists integrating AI into safety case review.
  3. Clinical Data Managers expanding into PV automation.
  4. Data Analysts / AI professionals entering pharma safety.
  5. Career changers moving into intelligent PV roles.
Benefits & Outcomes
  1. Gain practical skills in AI-enabled pharmacovigilance workflows.
  2. Automate case processing, coding, narratives, and reporting tasks.
  3. Build readiness for AI-driven safety and compliance roles in pharma and CROs.
  4. Enhance employability in digital PV and global safety operations.
  5. Be prepared for the future of intelligent and automated drug safety systems.
Career Pathways: After completing this course.
  1. AI-Enabled Drug Safety Associate (DSA)
  2. Pharmacovigilance Data Scientist
  3. Signal Detection & Risk Management Analyst
  4. Medical Reviewer (AI-supported)
  5. PV Operations & Compliance Manager

Curriculum & Modules

Modules
1. Introduction to AI in Pharmacovigilance

2. AI in Case Intake, Triage & Processing

3. NLP for Adverse Event Narratives & Literature Mining

4. AI-Assisted MedDRA & WHO-DD Coding

5. AI-Enhanced Signal Detection & Safety Analytics

6. Risk–Benefit Assessment Using Predictive Models

7. AI in Safety Databases (Argus, ArisG, Veeva Safety)

8. Regulatory Considerations for AI in PV (ICH-E2B, FDA, EMA)

9. Case Studies – AI in Global PV Operations

10. Future Trends – Digital PV & Intelligent Safety Systems
Getting in Touch:

For more information, please call us at +91 8925971788 / +91 8977943100 (WhatsApp)or email qpdc@qtechelearncenter.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.