AI-DRIVEN ANALYTICS – DRUG SAFETY / PHARMACOVIGILANCE - 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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AI-Driven Analytics – Drug Safety / Pharmacovigilance

Introduction – AI in Drug Safety & Pharmacovigilance

Pharmacovigilance (PV) teams face growing volumes of safety data from clinical trials, spontaneous reports, EHRs, and literature sources. Artificial Intelligence (AI) and Machine Learning (ML) are transforming PV by enabling automated case processing, intelligent signal detection, narrative analysis, and risk management.
The AIDS program introduces learners to AI applications in drug safety and pharmacovigilance, combining PV fundamentals with advanced AI-driven workflows. It prepares professionals for the next generation of safety operations, where automation and predictive insights improve efficiency, accuracy, and regulatory compliance.

Course Name :  AI-Driven Analytics – Drug Safety / Pharmacovigilance
Course Code :  AIDS
Experience Level :  Intermediate to Advanced
Qualification :  Bachelor’s / Master’s in Life Sciences, Pharmacy, Nursing, Medicine, Data Science, or related fields
Student Category :  Drug Safety Associates, PV Specialists, Medical Reviewers, Data Analysts, Career Changers into AI-enabled PV roles

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 supports PV workflows across clinical trials and post-marketing.
  3. Explore automation in ICSR intake, triage, and case processing.
  4. Learn how NLP enhances adverse event narrative analysis and medical text mining.
  5. Gain insights into AI-driven MedDRA/WHO-DD coding assistance.
  6. Apply AI for signal detection, risk evaluation, and decision support.
  7. Review compliance requirements for AI use in PV (ICH-E2B, FDA, EMA).
  8. Examine case studies of AI in safety databases and global PV operations.
Who Should Take This Course
  1. Drug Safety Associates (DSAs) & Specialists seeking AI-enabled skills.
  2. Medical Reviewers & PV Scientists interested in AI-driven case assessment.
  3. Clinical Data Managers collaborating with PV teams.
  4. Data Analysts / SAS Programmers working with safety data.
  5. Career changers targeting AI-enabled PV roles in pharma and CROs
Benefits & Outcomes
  1. Gain hands-on exposure to AI tools for pharmacovigilance.
  2. Automate case processing, coding, and safety reporting tasks.
  3. Improve efficiency in signal detection and risk management.
  4. Strengthen employability in AI-integrated drug safety roles.
  5. Be prepared for the future of digital and intelligent PV systems.
Career Pathways: After completing this course.
  1. AI-Enabled Drug Safety Associate (DSA)
  2. Pharmacovigilance Data Scientist
  3. Signal Detection Analyst
  4. Medical Reviewer (AI-supported)
  5. PV Operations Lead

Curriculum & Modules

Modules
1. Introduction to AI in Drug Safety & PV

2. AI in ICSR Intake, Triage & Case Prioritization

3. Natural Language Processing (NLP) for AE Narratives & Literature Mining

4. AI-Enhanced Coding (MedDRA, WHO-DD) & Data Validation

5. Signal Detection & Risk Evaluation Using Machine Learning

6. Predictive Models for Drug Safety & Benefit-Risk Assessment

7. AI-Enabled Safety Databases & Workflow Automation (e.g., Argus, ArisG)

8. Regulatory Considerations – ICH-E2B(R3), FDA, EMA, GDPR, HIPAA

9. Case Studies – AI in Global Pharmacovigilance Operations

10. Future Trends – AI, Cloud Integration & Digital 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.