BASICS OF ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS - Qtech-Sol offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Drug Safety
 
Duration:
3 Weeks / 80 Hours
 
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Basics of Adverse Events and Serious Adverse Events

Introduction – Basics of Adverse Events

AAdverse Events (AEs) and Serious Adverse Events (SAEs) are at the core of pharmacovigilance and clinical research safety monitoring. A clear understanding of these concepts is essential for professionals involved in clinical trials, drug development, or post-marketing surveillance.
The BSAE program introduces learners to the fundamentals of AEs and SAEs, equipping them with the knowledge to identify, classify, document, and report safety events in compliance with global regulatory requirements. This course serves as a building block for those pursuing careers in pharmacovigilance, clinical research, or regulatory affairs

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Course Name :  BASICS OF ADVERSE EVENTS (AES) AND SERIOUS ADVERSE EVENTS (SAES)
Course Code :  BSAE
Experience Level :  Entry Level
Qualification :  Bachelor’s in Life Sciences, Pharmacy, Nursing, Medicine, or related health sciences
Student Category :  Recent Graduates, Career Changers, Clinical & Healthcare Professionals

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 3 weeks (80 hours)
  2. Format: Self-Paced Online with Support (presentations, readings, quizzes, and case examples).
Key Learning Objectives

   By the end of this course, learners will be able to:

  1. Define Adverse Events (AEs) and Serious Adverse Events (SAEs).
  2. Understand the regulatory definitions and reporting timelines (FDA, EMA, ICH-GCP).
  3. Differentiate between expected vs. unexpected events and related vs. unrelated events.
  4. Learn the criteria for SAE classification (death, hospitalization, disability, life-threatening, congenital anomaly).
  5. Document AEs/SAEs accurately using case report forms (CRFs) and PV databases.
  6. Recognize the importance of MedDRA coding for standardizing event data.
  7. Appreciate the role of AEs/SAEs in signal detection and risk management
Who Should Take This Course
  1. Entry-level students aiming for PV or clinical research roles.
  2. Healthcare professionals (nurses, pharmacists, physicians) transitioning to safety monitoring.
  3. Clinical trial staff needing AE/SAE knowledge for site or sponsor roles.
  4. Career changers in life sciences entering drug safety.
Benefits & Outcomes
  1. Build a strong foundation in safety event identification and reporting.
  2. Learn compliance with regulatory reporting timelines.
  3. Be prepared for entry-level safety roles such as Drug Safety Assistant, Clinical Trial Coordinator, or PV Case Processor.
  4. Pathway to advanced training in Drug Safety Associate (DSAT), Argus Tool Workflow (ARGW), and Signal Detection (SDRM).
Career Pathways: After completing this course
  1. Drug Safety Assistant (DSA)
  2. Clinical Research Coordinator (CRC)
  3. Pharmacovigilance Case Processor
  4. Clinical Trial Assistant (CTA)
  5. Adverse Event Specialist

Curriculum & Modules

Modules
1. Introduction to Adverse Events in Clinical Research

2. Defining AEs vs. SAEs – Criteria and Classification

3. Expected, Unexpected, and Relatedness Assessments

4. Reporting Requirements & Timelines (FDA, EMA, ICH-GCP)

5. Documentation in CRFs and Safety Databases

6. Basics of MedDRA Coding for AE/SAE Entries

7. Case Studies – Real-World Examples of AEs & SAEs

8. AE/SAE Role in Signal Detection & Pharmacovigilance
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.