Diploma in Pharmacovigilance & Data Management


Oracle Argus Safety + Oracle Clinical – software access is included.




The Advanced Diploma in Pharmacovigilance & Data Management (ADPV-DM) is an e-learning program designed to provide students a complete understanding of Pharmacovigilance and Clinical Data management processes, regulations and documentation. It equips you to start a career in Drug Safety or as a Clinical Data Management professional. The course is delivered through our learning portal and is aligned to the requirements of the industry.

The Advanced Diploma in Pharmacovigilance & Data Management course is aligned to the requirements of the industry. It includes hands-on training modules on Oracle Argus Safety for Pharmacovigilance and Oracle Clinical for Clinical Data Management which are enterprise applications used in pharmacovigilance by most Fortune 500 pharmaceutical companies and contract research organizations.

The course comprises 14 modules, 125 chapters, 121 Quizzes and comprehensively covers all aspects of pharmacovigilance and clinical data management thus making you eligible for both roles in the industry. At the end of this you can choose to explore a career in pharmacovigilance or clinical data management domains. This enables you to be develop multiple skills and be eligible for a wider set of opportunities.

On completing your enrolment for the program you will instantly get access to our online learning portal and the relevant software.

This course includes access to latest version of Oracle Argus Safety – version and Oracle Clinical – version 5.4 software for hands on practical experience.

Key Features


  • Full access to e-Learning Portal containing Multimedia Tutorials, Recorded Lectures and Quizzes.
  • 24×7 access to Oracle Argus Safety software
  • 24×7 access to Oracle Clinical software
  • Course Instructor support via Discussion Forums


Course Stats – 14 Modules, 125 Chapters, 121 Quizzes


Module 1 – General Introduction
  • Pharmaceutical & CR – 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 – Epedemiology and Evidence Based Medicine (EBM)
  • Epidemiology 1 – Introduction
  • Epidemiology 2 – Concept of Causation
  • Epidemiology 3 – Epedemiological Study Designs
  • Epidemiology 4 – Statistics
  • Evidence Based Medicine
Module 3 – Pharmaceutical Medicine
  • Introduction to Pharmaceutical Medicine
  • Pre-clinical Development of Drugs and Biologics
  • Clinical Phases of Drug development
  • General Pharmacology
  • BA-BE Studies
  • Pharmacogenetics-Pharmacogenomics
  • Toxicology
  • Systemic Pharmacology
  • Clinical Trial Design
  • Intellectual Property Rights
  • Personalized Medicine
  • Clinical Trials in Pediatrics
  • Drug Safety in Pregnancy
  • Research Methods for Genetics Studies
  • Stem Cell Research and its Applications
  • Endpoints in Clinical Trials
  • Clinical Trial Registries
Module 4 – 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 5 – 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 6 – 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
  • Softwares used in Pharmacovigilance
Module 7 – Global Pharmacovigilance and Safety Standards
  • WHO & Safety Reporting
  • CIOMS Groups & Functions
  • Good Pharmacovigilance Practice
Module 8 – 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 9 – 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 10 – 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
Module 11 – Basics of Clinical Data Management
  • Introduction to Clinical Data Management
  • Application of Computers in Pharmaceutical Research & Development
  • Data Management Plan
  • Case Report Form Design
  • Patient Registration
  • Clinical Data Acquisition
  • Clinical Data Definition and Database Design
  • Training, Education, and Documentation Requirements
  • Safety Data Management
  • CDM Documentation Overview
Module 12 – Clinical Data Management Processes and Standards
  • Data Entry Methods and Processes
  • Database Validation and Standards
  • Database Closure
  • Clinical Data Management Audits
  • Measuring Performance in CDM
  • Data Validation and Query Management
  • Process of Drug Development
  • Clinical Data Management Process
  • Standard Operating Procedures
Module 13 – Clinical Data Management Systems
  • Clinical Data Management Systems
  • Database Migration and Archival
  • Medical Coding Dictionaries and MedDRA
  • Software Tools used in Management of Clinical Trials
  • Laboratory Data
  • Receipt and Review of Data
  • Data Presentation
  • Oracle Pharmaceutical Application Suite
Module 14 – Oracle Clinical Fundamentals
  • Oracle Clinical Navigation
  • Oracle Clinical Overview
  • Oracle Clinical – Planning a study
  • Oracle Clinical – Designing a study
  • Oracle Clinical – Global Library (DVGs, Questions, Question Groups)
  • Oracle Clinical – Definition subsystem (DCMs, DCIs, Layouts)
  • Oracle Clinical – Validation and Derivation Procedures
  • Oracle Clinical – Data Entry
  • Oracle Clinical – Discrepancy and DCF Management
Course Completion
  • Final Assessment
  • Course Certification



At the end of the course, students will be awarded a certificate of completion.



The duration of this program is 6 months.

You will have access to the course, Argus Safety and Oracle Clinical software for the duration of the program.


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