Diploma in Pharmacovigilance
Build comprehensive knowledge and practical skills in pharmacovigilance and drug safety through a flexible, self-paced online program.
Explore key areas including pharmacovigilance principles, adverse drug reactions, safety systems, global regulations, safety reporting and pharmacoepidemiology. Choose between an eLearning-only option or enhance your learning with hands-on access to Oracle Argus Safety.
Careers in Pharmacovigilance
On-Demand Webinar
Key Features
Here’s how you learn
Optional Hands-On Argus Safety Training
Choose the eLearning + software option to gain hands-on experience using Oracle Argus Safety for practical drug safety case management activities.
Recorded Sessions
Learn through recorded sessions covering key Pharmacovigilance concepts, processes and Oracle Argus Safety workflows.
Multimedia Tutorials
Access structured multimedia tutorials designed to support flexible, self-paced learning.
Quizzes and Assessments
Reinforce your learning through quizzes, graded assessments and practical assignments across the program.
Discussion Forums
Ask questions and interact with instructors through course discussion forums and learner support.
Certificate of Completion
Receive a ClinSkill Certificate of Completion after successfully meeting the program completion requirements.
Choose Your Learning Option
Diploma in Pharmacovigilance – eLearning
- —
- Multimedia Tutorials
- Recorded Lectures
- Graded Assessments and Quizzes
- Discussion Forums
- Certificate of Completion
Diploma in Pharmacovigilance + Oracle Argus Safety
- 24×7 access to Oracle Argus Safety
- Multimedia Tutorials
- Recorded Lectures
- Graded Assessments and Quizzes
- Discussion Forums
- Certificate of Completion
Curriculum
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 Topics.
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 Topics.
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 Topics.
Module 3 : Pharmacovigilance 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 Topics.
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 Topics.
Module 5 : Pharmacovigilance Regulations and Guidelines
This module will cover various guidelines and regulations governing Pharmacovigilance, and reporting requirements through ICSRs and PSURs.
5 Topics.
Module 6 : Pharmacoepidemiology
This module will introduce you to concepts and importance of Pharmacoepedemiology and the analysis of pharmacoepidemiological data.
10 Topics.
Module 7: Oracle Argus Safety Essentials
This module introduces the use of Oracle Argus Safety for managing drug safety data, including case entry and processing, case triage, medical coding, medical review, narrative writing, quality control, and safety reporting and submissions.
Hands-on Oracle Argus Safety login access is included with the eLearning + software option.
8 Topics.
Course Completion
Final Assessment.
Ezra Williams
“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. “
FAQ
What is Pharmacovigilance?
Pharmacovigilance is the science and activities concerned with the detection, assessment, understanding and prevention of adverse effects or other medicine-related problems. This program introduces key pharmacovigilance concepts, processes and drug safety activities.
Does the program include access to Oracle Argus Safety?
Software access depends on the learning option selected.
The eLearning + software option includes 24×7 access to Oracle Argus Safety for hands-on practice. The eLearning-only option includes the same core training and software demonstrations but does not include software login access.
What is the difference between the two learning options?
Both options include the same core pharmacovigilance curriculum, multimedia tutorials, assessments and Certificate of Completion.
The eLearning + software option additionally includes 24×7 access to Oracle Argus Safety for hands-on practice, while the eLearning-only option does not include software login access.
How long do I have access to the program and Oracle Argus Safety?
The program duration is 3 months, with flexible, self-paced access to the online learning portal.
Learners choosing the eLearning + software option also receive Oracle Argus Safety access for the duration of the program.
Will I receive a Certificate of Completion?
Upon successful completion of the program and final assessment, learners receive a ClinSkill Certificate of Completion.
What career areas can this program help me explore?
The program helps learners develop knowledge relevant to pharmacovigilance, drug safety, adverse event management and safety case processing. Depending on your qualifications, experience and employer requirements, this knowledge may support your exploration of roles and career pathways in pharmacovigilance and drug safety.