Diploma in Pharmacovigilance – eLearning

$499.00

Online eLearning program without software access.

Looking for hands-on Oracle Argus Safety training? Explore the Diploma with Oracle Argus Safety.

Description

The Diploma in Pharmacovigilance – eLearning is a comprehensive online program designed to build knowledge across the key principles, processes, regulations and practices of pharmacovigilance and drug safety.

Through structured, self-paced learning, multimedia tutorials, recorded sessions, quizzes and assessments, you will explore how safety information is collected, evaluated, managed and reported throughout the product lifecycle.

The program covers key areas including pharmacovigilance principles, adverse drug reactions, pharmacovigilance systems, global safety standards, regulatory requirements, safety reporting, MedDRA, literature review, Good Pharmacovigilance Practices, periodic safety reporting and pharmacoepidemiology.

The program also includes training/tutorial content covering Oracle Argus Safety and its role in drug safety case management. Hands-on login access to Oracle Argus Safety software is not included with this eLearning option.

Looking for hands-on software training?
Explore the Diploma in Pharmacovigilance with Oracle Argus Safety, which combines the pharmacovigilance curriculum with 24×7 access to Oracle Argus Safety for practical learning.

Program at a Glance

8 Modules | 63 Topics | 62 Quizzes

3 Months | Self-Paced Online Learning | Certificate of Completion

What You’ll Learn

  • Principles of pharmacovigilance and drug safety
  • Adverse drug reactions and post-marketing surveillance
  • Pharmacovigilance systems, processes and documentation
  • Individual Case Safety Reports (ICSRs) and safety reporting
  • MedDRA and medical coding concepts
  • Global pharmacovigilance regulations and safety standards
  • Good Pharmacovigilance Practices
  • Periodic and aggregate safety reporting
  • Pharmacoepidemiology and safety data analysis
  • Oracle Argus Safety concepts and drug safety case management workflows

Who Is This Program For?

  • Students and graduates interested in pharmacovigilance and drug safety
  • Pharmacy, life sciences, medical and healthcare graduates
  • Healthcare professionals exploring pharmacovigilance
  • Professionals transitioning into pharmacovigilance or drug safety
  • Pharmacovigilance professionals looking to strengthen their knowledge across key functional areas
  • Learners seeking flexible, self-paced pharmacovigilance training

Looking for Hands-On Oracle Argus Safety Training?

This eLearning program includes Oracle Argus Safety training/tutorial content but does not include login access to the software.

If you would also like to practise drug safety case management activities directly within Oracle Argus Safety, explore the Diploma in Pharmacovigilance with Oracle Argus Safety. This option combines the complete pharmacovigilance curriculum with 24×7 software access for hands-on practice.

Explore Program with Argus Safety

New to pharmacovigilance? Explore our free learning resource on What is Pharmacovigilance.

Explore more Pharmacovigilance courses and training programs.

Key Features

  • Comprehensive pharmacovigilance curriculum covering key drug safety concepts and processes
  • 8 modules, 63 topics and 62 quizzes
  • Multimedia tutorials and recorded sessions
  • Oracle Argus Safety training/tutorial content
  • Flexible, self-paced online learning
  • Quizzes and assessments to reinforce learning
  • Instructor support through discussion forums
  • Certificate of Completion

Curriculum

Module 1 – Introduction to Clinical Research
  • Pharmaceutical and Clinical Research – Industry Overview
  • Introduction to Clinical Research
  • Stakeholders and Roles in Clinical Research
  • History and Milestones in Clinical Research
  • Principles of Good Clinical Practice
  • Technologies in Clinical Trial Management
  • Overview of Clinical Research Regulatory Bodies
Module 2 – Principles of Pharmacovigilance
  • General Overview of Pharmacovigilance
  • History and Aim of Pharmacovigilance
  • Drug Dependence
  • Vaccine Vigilance
  • Principles of Signal Detection in Pharmacovigilance
  • Communication in Pharmacovigilance
  • Post-Marketing Surveillance
Module 3 – Pharmacovigilance and Selected System Organ Classes
  • Dermatological ADRs
  • Gastrointestinal ADRs
  • Haematological ADRs
  • Renal ADRs
  • Ocular Side Effects of Prescription Medications
  • Drug Safety in Pregnancy
  • Hepatic Drug Reactions
  • Anaesthetic Adverse Drug Reactions
  • Pharmacovigilance in Pediatrics
  • The Cardiovascular Spectrum of Adverse Drug Reactions
  • Drugs and the Elderly
Module 4 – Pharmacovigilance Systems
  • Audits and Inspections in Pharmacovigilance
  • Pharmacovigilance Department
  • Qualified Person for Pharmacovigilance
  • Standard Operating Procedures in Pharmacovigilance
  • Literature Review
  • MedDRA
  • Eudravigilance
  • Assessment of Compliance
  • Mergers and Acquisitions
  • Software used in Pharmacovigilance
Module 5 – Global Pharmacovigilance and Safety Standards
  • WHO & Safety Reporting
  • CIOMS Groups & Functions
  • Good Pharmacovigilance Practice
Module 6 – Pharmacovigilance Regulations and Guidelines
  • Safety Reporting
  • Individual Case Safety Reports
  • Periodic Safety Update Reports
  • Indian Regulations with specific reference to Schedule Y
  • Regulatory Pharmacovigilance in EU
Module 7 – Pharmacoepidemiology
  • Introduction to Pharmacoepidemiology
  • Molecular Genetic Pharmacoepidemiology
  • Analysis of Pharmacoepidemiological Data
  • Studies of Drug Use
  • Case-Control Studies
  • Cohort Studies
  • Data Sources
  • Measures of Frequency & Risk
  • Advanced Issues in Pharmacoepidemiology
  • Errors in Pharmacoepidemiology
Module 8 – Oracle Argus Safety Essentials

This module provides learning content about Oracle Argus Safety. Hands-on software access is not included with this program.

  • Overview and Navigation
  • Overview of Argus Menus
  • Case Form Features
  • Drug and Event Coding
  • Case Entry and Processing
  • Advanced Conditions
  • Reporting and Submissions
Course Completion
  • Final Assessment
  • Course Certification

 

 

Certification

Upon successful completion of the program and final assessment, learners receive a ClinSkill Certificate of Completion.

Duration

The program duration is 3 months, with flexible, self-paced access to the online learning portal.

Learners have access to the course, including Oracle Argus Safety training/tutorial content, for the duration of the program. Login access to the Oracle Argus Safety software is not included with this eLearning option.

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