Diploma in Pharmacovigilance  3 months

The Professional Diploma in Pharmacovigilance is an eLearning program that comprehensively covers the concepts, processes, regulations and standards in Pharmacovigilance. It also covers the process of management of drug safety data in Oracle Argus Safety.

What you Get by Enrolling

Here’s how you learn

24x7 access to Argus Safety

Get hands-on practical experience on conducting pharmacovigilance processes by working on the Oracle Argus Safety software.

Recorded Sessions

Get access to recorded video lectures from our expert industry faculty that demonstrate all activities performed in Oracle Argus Safety.

Multimedia Tutorials

Our multimedia tutorials are handcrafted for a more holistic learning experience. Access Computer Based Trainings (CBTs) on all Oracle Argus Safety activities.

Quizzes and Assessments

The program includes a Quizzes and Practical Assignments for each chapter to assess you understanding of the subject and provide feedback.

Discussion Forums

Each chapter includes a Discussion Forum. Post your Question. Get an answer from our Faculty. Its really that simple!.

Certificate of Completion

Earn Badges as your learn. Download the Certificate of Completion when you meet the course completion criteria for the program.

Program Curriculum

Here’s what you learn

Preliminary Module : Introduction to Clinical Research

In this module you shall learn the important concepts of Clinical research which are essential to understand to develop preliminary understanding of Pharmacovigilance and Oracle Argus Safety.

7 chapters.

Module 1 : Principles of Pharmacovigilance

This module will introduce you to the general overview of field of Pharmacovigilance, its history, aim and some of the other core principles of Pharmacovigilance.

8 chapters.

Module 2 : Pharmacovigilance and System Organ Classes

In this module you will learn the concepts of Pharmacovigilance and the management of Adverse Drug reactions for individual Therapeutics areas.

11 chapters.

Module 3 : Pharmacoviigilance Systems

In this module you will learn about the various systems and personnel in Pharmacovigilance including the importance of SOPs, Audits and assuring regulatory compliance.

10 chapters.

Module 4 : Global Pharmacovigilance and Safety Standards

In this module you will learn about the WHO safety standards and best practices used in pharmacovigilance reporting.

3 chapters.

Module 5 : Pharmacovigilance Regulations and Guidelines

This module will cover various guidelines and regulations governing Pharmacovigilance, and reporting requirements through ICRSs and PSURs.

5 chapters.

Module 6 : Pharmacoepedemiology

This module will introduce you to concepts and importance of Pharmacoepedemiology and the analysis of pharmaco-edpedemiological  data.

10 chapters.

Module 7 : Oracle Argus Safety Essentials

This module will cover the process of collecting, triaging, managing, reviewing and reporting Pharmacovigilance data using the Oracle Argus Safety software.

8 chapters.

Course Completion

This course completion module, includes a Final Quiz that you will need to take to complete this course. The marks of the final quiz will be added to the marks of all other graded activities of this course. If your total score in the course is 75% and above, you will be able to see a Course completion certificate which you can then download.

Final Assessment.

Ezra Williams

Student

“The program was well drafted and comprehensive. It included all the core concepts in Pharmacovigilance. The tutorials had voice-over which made it really easy to understand and listen to them while on the go. Argus Safety software access was provided as promised and it helped me apply the concepts and get hands-on practical experience in managing drug safety cases. I would highly recommend this program to everyone. “

Course Fee

Choose a Learning style that suits you.

FAQ

Here are some questions we get asked often about this course

What is Oracle Argus Safety?

Oracle Argus Safety is a software application used for the collection, management and reporting of Adverse Events and Serious Adverse Events (SAEs) generated during clinical trials. It is used by most of the Fortune 500 companies. It is a part of a larger suite of applications called the Oracle Pharmaceutical applications suite (OPA)..

Will i get access to Oracle Argus Safety software?

Yes, you will be able to access the Argus Safety application 24×7 from your home throughout the duration of the program. Your credentials to access the software shall be emailed to instantly on enrollment in the program. The duration of access to the software is 3 months.

Do i receive a Certificate of Completion?

On successful completion of the program, students will be awarded a Certification. We lay a strong focus on the quality of learning. To acheive ceritication, you will need to complete all graded Tutorials, Quizzes, Assignments and a Final Examination at the end of the program.

What is included in Diploma in Pharmacovigilance?

Diploma in Pharmacovigilance is an eLearning program and is designed to be a self-paced learning course. You will get access to our Online Learning Portal and will learn through recorded sessions, tutorials and assignments. You can get your queries answered through Support Tickets and Discussion forums.

Who will answer my Queries?

Every chapter in the course will have a Discussion forum. When you post a query in the Forum, the Course instructor will reply to it. You can also directly message the course instructor from within the Learning portal. For urgent inquires you can also raise a support ticket on our Support Portal.

What jobs am i eligible for after the Course?

On successful completion of the program you will be elligible for the roles of a Drug Safety Associate, Pharmacovigilance officer, Drug Safety Data Manager, Pharmacovigilance Scientist, Risk Management Specialist, Senior Vigilance Manager and Signal Detection Specialist.

Ready to get started?

Get in touch, or enroll in the course