Enhancing Drug Safety Through Skilled Professionals
The Professional Certificate in Pharmacovigilance (PCPV) is an industry-aligned drug safety training program that equips learners with essential skills in pharmacovigilance, case processing, signal detection, and global safety regulations. This comprehensive certification prepares professionals for growing career opportunities across pharmaceutical companies, CROs, and medical institutions.
Participants receive carefully structured learning module supported by practical case examples and assessments, offering a clear understanding of end-to-end pharmacovigilance processes. Delivered through a flexible distance-learning format over a span of six months, the PCPV programme allows participants to learn at their convenience while balancing academic, professional, or personal responsibilities.
Ideal for graduates and working professionals aspiring to build a career in drug safety, the PCPV equips learners with industry-ready skills, globally relevant knowledge, and the confidence required to excel in a highly regulated and mission-critical field.
What you'll learn
Master global drug safety regulations and authorities
Capture and document safety events per international standards
Evaluate safety data with consistent, compliant methods
Apply standard medical terminologies for harmonized reports
Detect signals and analyze patterns for emerging risks
Support balanced risk-benefit decisions with evidence
Why choose this Course?
Self-Paced Learning
Flexible format that fits around professional or academic schedules.
24/7 Expert Academic Support
24/7 faculty guidance for queries, feedback, and learning clarity.
Industry-Ready Content
Curriculum mapped to current industry practices and GCP standards.
A Standout Portfolio
Assignments that showcase trial design and operational know-how.
Real-World Projects & Case Studies
Applied real-world case studies reflecting actual scenarios.
Placement Assistance
Career guidance and interview readiness for industry roles.
Course Details
Module 1: Introduction to Pharmacovigilance and Risk Management
Duration: Self-Paced
Topic Covered
Standard Terms and Definition of Pharmacovigilance
Global Perspectives PV and ADR Reporting
Functions of a National Pharmacovigilance System
Minimum Requirements for a Functional National Pharmacovigilance System
Basic Steps in Setting up a Pharmacovigilance Centre
How to Join the WHO Program for International Drug Monitoring?
Procedure for Joining the WHO Drug Monitoring Program
Pharmacovigilance Methods
Relationship/Casualty Assessment
Signal Generation in Pharmacovigilance
Skills Acquired
Pharmacovigilance fundamentals
Risk management basics
Causality and signal concepts
National PV system setup
ADR collection and reporting
Module 2: Guidelines and Standards Governing PV
Duration: Self-Paced
Topic Covered
ICH Guidelines
US-FDA Guidelines
CFR Guidelines
European Union Guidelines
CIOMS Guidelines
Joint CIOMS-WHO Working Group on Drug Development Research and Pharmacovigilance in Resource-Poor Countries (2006)
CIOMS-WHO Working Group on Vaccine Pharmacovigilance
Pharmacovigilance Program of India (PVPI)
List of ADR Monitoring Centres under PVPI
Skills Acquired
ICH/FDA compliance literacy
EU and CIOMS guideline application
Vaccine PV practices
PVPI processes and centres
Global regulatory navigation
Module 3: Global AE Reporting Systems and Forms
Duration: Self-Paced
Topic Covered
Definitions and Terminology Associated with Clinical Safety
Experience, ICH (E2A)
Expectedness of an Adverse Drug Reaction
Reporting of Adverse Drug Reactions
ADR/AE Reporting Procedure
AE Reporting Form: - MedWatch Form 3500 and 3500A - Yellow Card - CIOMS I Form - SADRR Form - Blue Card - VAERS, etc.
Skills Acquired
AE terminology and classification
Expectedness and seriousness assessment
ADR/AE reporting workflows
Global reporting forms proficiency
Regulatory timeline adherence
Module 4: Individual Case Safety Reports (ICSRs)
Duration: Self-Paced
Topic Covered
Medical Directory for Drug Regulatory Activities (MedDRA)
Periodic Safety Updates Reports (PSURs)
Expedited Reporting and Requirements
Pharmacovigilance Inspections
Skills Acquired
MedDRA coding accuracy
PSUR drafting fundamentals
Expedited reporting criteria
Inspection readiness
Case quality review
Course Schedule
1
Receive Study Material
Upon registration, you will receive four comprehensive Learning Modules along with an Assignment Workbook.
2
Study & Complete Assignments
Go through the modules and complete the assignments within the standard 4.5-month duration.
3
Option for Early Completion
If you wish to finish sooner, you may submit your completed workbook with an early assessment request.
4
Assessment
Your Assignment workbook is evaluated based on the qualification criteria.
5
Earn Your Certificate
After successful assessment, you will be awarded a Certificate of Completion.
Registration Process
Three-step registration process:
1
Get the Registration Link/QR
Receive the registration link and QR code from us.
2
Complete the Form & Payment
Fill out the registration form and pay the course fee using the QR code.
3
Receive Confirmation
Get an acknowledgement call confirming your successful registration.
Program Fee
Indian Participants
₹14000
Foreign Participants
$350
This course includes
Duration
Self-Paced
Lessons
4
Students
500+
Language
English
Certificate
Yes
Contact for more details of the course
Student Testimonials
This course transformed my career! The hands-on projects and expert guidance helped me land my dream job as a React developer.
JD
- John Doe
I highly recommend this course to anyone looking to master React. The curriculum is well-structured, and the instructors are knowledgeable and supportive.
JS
- Jane Smith
The practical approach of this course made learning React enjoyable and effective. The projects were challenging yet rewarding, and I gained real-world skills.
MJ
- Mike Johnson
As a beginner, I was initially intimidated by React, but this course broke down complex concepts into easy-to-understand lessons. The community support was also fantastic!
ED
- Emily Davis
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