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Certificate Course in Pharmacovigilance

Course Objectives:

Suitable for: Freshers, Pharmacy and Medical Students, trainers, academicians, Industry aspirants, and individuals who are new in the industry

To Learn the basics of Pharmacovigilance, Cosmetovigilance and Device Vigilance

 

  • History of Pharmacovigilance, and the importance
  • Introduction to concepts such as Day Zero, Four Minimum Criteria, Seriousness, Causality, and Dechallenge-Rechallenge, Adverse Event Vs Adverse Drug Reaction, causality, medical coding and Sources of Adverse Events
  • Case Processing and Aggregate Safety Reporting
  • Medical Information, Device Vigilance, EcoPharmacovigilance, Cosmetovigilance, and Hemovigilance
  • Vaccine Adverse Event Reporting System
  • Setting up a Pharmacovigilance Sytem
  • Quality Management System in Pharmacovigilance
  • Audits and Inspections
  • Pharmacovigilance Resources
  • Interview Questions
  • Career Opportunities
COURSE FEE: Rs 499 (US$11 for Overseas Participants)
(This includes all future updates and additional modules, Mock Interviews, etc.)
 
Mode: Self Learning + Live Webinar sessions with the Industry Experts for Doubt Solving
Course Hours: 25
Assessment – Yes
Certificate – YES
 
 

About the Course Designer: LINKEDIN PROFILE 

VigiServe Foundation is a registered Non-Profit in India (CIN U85300MH2020NPL339935)with a mission of Empowering Public Health by ensuring safe medicines and promoting a culture for reporting Adverse Drug Experiences and Side Effects. 

DONATE: https://www.vigiserve.com/donate

How will the Certificate look like?

Review of the Students from the courses conducted in the past:

 

Review 1

Review 2

Review 3

Review 4 (International Students)

Module 1 - Pharmacovigilance Basics

Module 2 - Case Processing

Module 3 - Literature and Social Media Monitoring

Module 4 - Aggregate Safety Reporting and Benefit-Risk Management

Module 6 - Pharmacovigilance Quality

Module 10 - Patient Safety - Beyond Pharmacovigilance

Module 12 - A Successful Career in the field of Pharmacovigilance and Patient Safety

Graduates in Medicine, Pharmacy, Science, Nursing, etc.
Undergraduate Students in Medicine, Pharmacy, Science, Nursing, etc.
Academicians, Industry personnel, etc.
Only that you should have access to YouTube and www.vigiservefoundation.org
-Some students/academicians genuinely wish to learn Pharmacovigilance.
-Most of the Pharmacovigilance courses available today have a commercial motive.
-The industry professionals too get limited exposure to the various topics in Patient Safety

To address all these requirements, VigiServe Foundation has come up with this initiative, where quality content will be available at nominal rates.
Yes; we can arrange on-demand Microsoft Teams meetings with the industry experts for the course participants, over the weekends.
Yes, this is a full-fledged course that will take 25 hours to complete

VigiServe Foundation is a registered not-for-profit organization. Funds are required for the day-to-day operations and for maintaining the learning management systems, company website, and also for coming up with new learning modules.
Yes; you can check https://www.vigiservefoundation.org/courses/ for more details. More than 4000 students globally have been benefited
VigiServe Foundation is a registered Non-Profit in India (CIN U85300MH2020NPL339935)with a mission of Empowering Public Health by ensuring safe medicines and promoting culture for reporting Adverse Drug Experiences and Side Effects.
We will provide relevant links to the course materials. Most of these materials have been prepared by VigiServe Foundation. Besides, we will also share the links to the necessary websites
Yes, we have a student and course reference number published on the top of the certificate. This makes it unique
Yes, you can generate it on your own. It is recommended to use a PC/Laptop for downloading the certificate.
You can find them on https://www.vigiservefoundation.org/activities/

A fully online, self-learning certification course in Pharmacovigilance from the VigiServe Academy for Patient Safety.

Learn at your own pace!

VigiServe Foundation is a registered Non-Profit in India (CIN U85300MH2020NPL339935) with a mission of Empowering Public Health by ensuring safe medicines and promoting a culture for reporting Adverse Drug Experiences and Side Effects.

The Course Modules

Introduction and History

•                    Introduction to Pharmacovigilance

•                    History of Pharmacovigilance

•                    Need for a Certification Course in Pharmacovigilance

•                    Take and Tell

•                    Introduction to Pharmacovigilance – Quiz

Module 1 - Pharmacovigilance Basics

•                    Four Minimum Criteria for Case-Report Validity

•                    Four Minimum Criteria – Quiz

•                    Day Zero

•                    Day Zero – Quiz

•                    Adverse Event Vs Adverse Drug Reactions

•                    AE Vs ADR – Quiz

•                    Source of Adverse Event Reports

•                    Sources of Adverse Events – Quiz

•                    Dechallenge and Rechallenge in Pharmacovigilance

•                    Dechallenge and Rechallenge – Quiz

•                    Basics – Assignment

Module 2 - Case Processing

•                    Seriousness Assessment in Pharmacovigilance

•                    Seriousness Criteria – Quiz

•                    Event outcome in Pharmacovigilance

•                    Event outcome in Pharmacovigilance – Quiz

•                    Case-Narratives in Pharmacovigilance

•                    Narrative Writing – Quiz

•                    Medical Coding in Pharmacovigilance

•                    Medical Coding in Pharmacovigilance – Quiz

•                    Causality Assessment in Pharmacovigilance

•                    Causality Assessment – Quiz

•                    Medical Review in Pharmacovigilance

•                    Medical Review in Pharmacovigilance – Quiz

•                    Labeledness Vs Listedness Vs Expectedness in

•                    Expectedness, Labeledness and Listedness – Quiz

Module 3 - Literature and Social Media Monitoring

•                    Literature Safety Monitoring in Pharmacovigilance

•                    Literature Safety Monitoring – Quiz

•                    Social Media Monitoring in Pharmacovigilance

•                    Social Media Monitoring in Pharmacovigilance – Quiz

Module 4 - Aggregate Safety Reporting and Benefit-Risk Management

•                    Aggregate Safety Reporting – An Introduction

•                    Aggregate Safety Reporting – Quiz

•                    Signal Management

•                    Signal Management – Quiz

•                    Black Triangle and Black box Warnings

•                    Black Triangle and Black box Warnings - Quiz

Module 5 - SDEA and PSMF Management

•                    Safety Data Exchange Agreement

•                    Need for a Safety Data Exchange Agreement

•                    Introduction to SDEA – Quiz

•                    Pharmacovigilance System Master File

•                    PSMF – Intro – Quiz

Module 6 - Pharmacovigilance Quality

•                    Quality Management System in Pharmacovigilance

•                    QMS in Pharmacovigilance – Quiz

•                    Audit Vs Inspection

•                    Audit Vs Inspection -Quiz

•                    QPPV

•                    QPPV-Quiz

•                    WHO PHV Resources

•                    Setting up a PHV System

•                    Variation in Country Specific Requirements

•                    Country Specific Requirements – Quiz

Module 7 - Medical Information

•                    Medical Information

•                    Global Medical Information – Quiz

Module 8 - Product Complaints

•                    Product Quality Complaints

•                    Product Quality Complaints – Quiz

•                    Product use alterations

•                    Product use alterations – Quiz

Module 9 - Vaccines' Safety

•                    Vaccine Adverse Event Reporting System

•                    Vaccines’ Safety Monitoring – Quiz

Module 10 - Patient Safety - Beyond Pharmacovigilance

•                    Medical Device Vigilance

•                    Medical Device Vigilance – Quiz

•                    Cosmetovigilance

•                    CosmetoVigilance – Quiz

•                    Hemovigilance (Blood Safety)

•                    Hemovigilance – Quiz

•                    Veterinary Pharmacovigilance

•                    Veterinary Pharmacovigilance – Quiz

•                    EcoPharmacovigilance

•                    EcoPharmacovigilance – Quiz

•                    Pharmacogenomics in Pharmacovigilance

•                    Pharmacogenomics - Quiz

Module 11 - A Successful Career in the field of Pharmacovigilance

•                    Designing a good CV or Resume for getting a dream job in Pharmacovigilance

•                    Using the right keywords in your Resume

•                    Preparing for a Pharmacovigilance Job Interview

•                    Effective Networking on LinkedIn

•                    A Career in the Pharmacovigilance Industry

•                    Career in Pharmacovigilance – Quiz

•                    Final Assessment

 

Final Assessment

 

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Enrolled: 54 students
Duration: 25 Hours
Lectures: 64
Video: 18 Hours
Level: Intermediate

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