Professional Certificate in Pharmacovigilance

Categories: Pharmacovigilance
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About Course

Launch Your Career in Drug Safety and Global Healthcare

The Professional Certification in Pharmacovigilance by the Institute of Advanced Skill
Development (IASD) is an accelarated 3-month, 100% online, industry-aligned training program designed for students and professionals in pharmacy, life sciences, biotechnology,microbiology, and allied health sciences.

Pharmacovigilance is a critical function in the pharmaceutical industry that focuses on detecting, assessing, and preventing adverse effects of medicines. With the global demand for drug safety professionals rising, this course prepares you for high-potential roles such as:

• Drug Safety Associate
• Pharmacovigilance Officer

• Case Processor
• Medical Reviewer
• Clinical Safety Analyst

🧠Key Features:

• Pre-recorded video lectures by industry experts
• Downloadable study materials, case studies & templates
• Quizzes and assignments to test real-world application
• Discussion forums and peer collaboration
• Live mentorship classes and career guidance
• IASD Certification upon successful completion

🎯Who Should Enroll:

• Final-year or graduate students in B.Pharm, M.Pharm, B.Sc., M.Sc. (Life Sciences)
• Job seekers looking for a career in drug safety, CROs, or pharma companies
• Working professionals aiming to shift to pharmacovigilance roles

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What Will You Learn?

  • • Fundamentals of Pharmacovigilance and Drug Regulation
  • • Adverse Event Reporting (ICSR, SUSAR, MedDRA Coding)
  • • Introduction to Oracle Argus Safety and Industry Tools
  • • Signal Detection and Risk Management
  • • Case Narratives and Medical Terminology
  • • Audit, Compliance & Global Regulatory Frameworks

Course Content

Introduction to Pharmacovigilance
History and evolution of pharmacovigilance Pharmacovigilance, as a scientific discipline, finds its roots in a series of tragic events in medical history. One of the most defining moments was the thalidomide disaster of the early 1960s, where the use of thalidomide in pregnant women for morning sickness led to over 10,000 children being born with severe limb deformities. This global tragedy led to the realization that robust systems were needed to monitor the safety of medicines postmarketing. The World Health Organization (WHO) took a pioneering role in establishing the Programme for International Drug Monitoring in 1968. Over time, various national pharmacovigilance systems were developed, and the discipline has evolved into a comprehensive framework that spans adverse drug reaction (ADR) reporting, risk management, benefit-risk evaluation, and regulatory compliance. The evolution continues today with the integration of new technologies, real-world evidence, and patient-reported outcomes.

  • Historical background and evolution
    01:30:00
  • Definition, scope, and importance
    01:30:30
  • Role of PV in the drug development lifecycle
    01:30:08
  • Key stakeholders (Regulators, CROs, Pharma companies)
    01:01:00
  • Quiz 01

Global Regulatory Environment

Adverse Drug Reactions (ADRs)
Adverse Drug Reactions (ADRs) are harmful or unintended responses to drugs at normal doses. They are broadly classified into Type A (augmented) reactions, which are dose-dependent and predictable (e.g., bleeding with warfarin), and Type B (bizarre) reactions, which are dose-independent, unpredictable, and often immune-mediated (e.g., anaphylaxis with penicillin). Reporting timelines require serious ADRs (life-threatening, fatal, causing hospitalization or disability) to be reported within 24 hours/7–15 days, while non-serious ADRs are reported within 90 days. WHO causality assessment classifies ADRs as certain, probable, possible, unlikely, conditional, or Un assessable. The Naranjo Scale is a structured questionnaire used to determine the likelihood of drug causality.

Individual Case Safety Reports (ICSRs)

Case Processing Workflow

Signal Detection & Risk Management

Safety Database Training

Career Preparation & Certification

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