INTRODUCTION TO PHARMACOVIGILANCE & DRUG SAFETY - 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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Introduction to Pharmacovigilance and Drug Safety

Introduction – Pharmacovigilance & Drug Safety

Pharmacovigilance (PV) and Drug Safety are at the heart of protecting patients and ensuring the safe use of medicines worldwide. With increasing regulatory demands, complex global trials, and vast amounts of post-marketing safety data, drug safety professionals are in high demand.

The Introduction to Pharmacovigilance & Drug Safety (IPDS) program provides learners with a comprehensive foundation in drug safety principles, processes, and regulations. It is tailored for individuals beginning their careers in PV, or professionals from healthcare, life sciences, or clinical research looking to transition into this critical field.

Course Name :  Introduction to Pharmacovigilance & Drug Safety
Course Code :  IPDS
Experience Level :  Entry-Level
Qualification :  Bachelor’s in Life Sciences, Pharmacy, Nursing, Medicine, Public Health, or related fields
Student Category :  Recent Graduates, Career Changers, Healthcare / Clinical 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 (narrated lessons, readings, quizzes, and role-based tasks).
Key Learning Objectives

   By the end of this course, learners will:

  2. Understand the fundamentals of pharmacovigilance and drug safety.
  3. Learn about the drug development process and where PV fits within clinical trials and post-marketing.
  4. Define and differentiate adverse events (AEs) and serious adverse events (SAEs).
  5. Recognize the importance of case processing, triage, and MedDRA coding.
  6. Gain an introduction to regulatory authorities and guidelines (FDA, EMA, ICH-GCP, HIPAA, 21 CFR Part 11).
  7. Explore the roles and responsibilities of PV professionals, including safety reporting and communication.
  8. Appreciate the ethical and regulatory obligations in monitoring patient safety.
Who Should Take This Course
  1. Fresh graduates in life sciences or pharmacy seeking entry-level PV roles
  2. Healthcare professionals (nurses, pharmacists, physicians) expanding into drug safety careers
  3. Clinical research staff transitioning into pharmacovigilance
  4. Career changers with science/health backgrounds interested in PV
Prerequisites
  1. Basic knowledge of life sciences or healthcare concepts
  2. Familiarity with clinical research principles is helpful but not mandatory
  3. Computer literacy (MS Office, database navigation)
Benefits & Outcomes
  1. Develop a strong foundation in pharmacovigilance and drug safety.
  2. Gain readiness for entry-level PV roles such as Drug Safety Assistant or PV Coordinator.
  3. Learn key terms, processes, and regulatory expectations from day one.
  4. Improve employability with a recognized certificate of completion.
  5. Pathway to advanced PV programs (DSAT, ADSA, SDRM, PVIR).
Career Pathways: After completing this course
  1. Drug Safety Assistant (DSA)
  2. Pharmacovigilance Coordinator
  3. Adverse Event Case Processor
  4. Clinical Safety Associate
  5. Regulatory Affairs Trainee
Professional Organizations & Resources
  1. DIA – Drug Information Association
  2. ISoP – International Society of Pharmacovigilance
  3. RAPS – Regulatory Affairs Professionals Society
  4. Journals: Drug Safety, Journal of Pharmacovigilance, Pharmacoepidemiology & Drug Safety
  5. Regulatory Websites: FDA, EMA, MHRA, Health Canada

Curriculum & Modules

Introductory Lessons
1. Introduction to Pharmacovigilance & Public Health – Role of PV in protecting patients and ensuring medicine safety.

2. Drug Development & Clinical Trials (Phases I–IV) – How PV integrates across the drug development lifecycle.

3. Adverse Events (AE/SAE) & Reporting – Key definitions, reporting criteria, and their importance.

4. Sources of Safety Data – Clinical trials, literature, registries, and spontaneous reports.

5. Case Processing & Triage – Basics of handling, prioritizing, and processing safety cases.

6. MedDRA & WHO-DD Coding – Introduction to medical dictionaries for standardized coding.

7. Regulatory Authorities & Guidelines – Overview of FDA, EMA, ICH-GVP, HIPAA, and compliance frameworks.

8. Signal Detection & Risk Management – High-level view of how signals are identified and risks managed.

9. Periodic Safety Reporting – Basics of PSURs and DSURs for continuous safety monitoring.

10. Roles in PV – Entry to advanced roles: DSA, PV Specialist, Safety Officer, Medical Reviewer.

11. Documentation & Audit Readiness – Importance of SOPs, compliance, and inspection preparedness.

12. Career Pathways in PV – Growth opportunities and progression within drug safety.
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.