The Professional Diploma in Pharmacovigilance (PDPV) is an online eLearning course that covers the core concepts of management of drug safety data and equips you to start a career in Pharmacovigilance domain. The course is aligned to the requirements of the industry and imparts process knowledge of how drug safety data is managed in a clear and concise manner so that you may kickstart a career in pharmacovigilance.
The course includes hands-on practical training on Oracle Argus Safety software used as a de-facto standard for managing drug safety data.
The Diploma in Pharmacovigilance program is made up of 8 modules, 63 topics and 62 Quizzes. It covers the overview of clinical research, pharmacovigilance processes, drug safety regulations and pharmacovigilance systems.
The final module of the course covers the process of managing drug safety data using the Oracle Argus Safety application. This module covers all the pharmacovigilance tasks performed in Oracle Argus Safety including Case entry, Case Triage, Medical coding, Medical review, Narrative writing, Quality control and Reporting.
On completing your enrolment for the Diploma in Pharmacovigilance program you will instantly get access to our online learning portal and the Oracle Argus Safety software.
This course includes access to latest version of Oracle Argus Safety – version 22.214.171.124 for hands on practical experience.
Find more information about the field of Pharmacovigilance – What is Pharmacovigilance.
Course Stats – 8 Modules, 63 Chapters, 62 Quizzes
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
- Assessment of Compliance
- Mergers and Acquisitions
- Softwares 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 – Pharmacoepedemiology
- 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
- Overview and Navigation
- Overview of Argus Menus
- Case Form Features
- Drug and Event Coding
- Case Entry and Processing
- Advanced Conditions
- Reporting and Submissions
- Final Assessment
- Course Certification
At the end of the course, students will be awarded a certificate of completion.
The duration of this program is 3 months.
You will have access to the course, and Oracle Argus Safety software for the duration of the program.