Job Oriented Certificate Course In Pharmacovigilance

A Pharmacovigilance Course for Beginners by PV Drug Safety Academy

What you'll learn
Pharmacovigilance: Definition, History, and objectives
Adverse event, Adverse drug reaction and Side effects
Event seriousness, causality and labelling
Case triage, Case validity criteria, Case submission timelines and Sources of ICSR
Dechallenge, Rechallenge, SUSAR criteria, Regulatory Authorities
Special situation scenarios, Basics of MedDRA and WHODD
Practical Demo and Additional Guidance sessions

Requirements
Basic level of English
Good quality of Internet connection
Desktop, Laptop or Smartphone

Description
This course is designed for Pharma students, Doctors and Life science graduates. This is a unique course for Fresher’s which can help them to understand Basics and Intermediate level of Pharmacovigilance (PV) concepts. This course will also be helpful to those who have early stage experience in Pharmacovigilance.The salary for Pharmacovigilance professional in India for fresher’s ranges between 2.5 Lakhs to 5.0 Lakhs.The trainer of this course have more than 10 years of Pharmacovigilance Industry Experience from different multinational companies. He has expertise in ICSR, Aggregate Reports, Signal and Risk Management.In this course we have covered following topics:Introduction of this courseWhat is PharmacovigilanceHistory of PharmacovigilanceObjectives of PharmacovigilanceAE, ADR and Side EffectsEvent seriousnessCausality AssessmentLabellingMinimum criteria for case validityCase triageCase NarrativeCase submission timelines to regulatory authorityDechallenge/ Rechallenge conceptSources of ICSRSUSAR and Its ImportanceSpecial situation scenariosBasics of MedDRABasics of WHO Drug DictionaryImportant regulatory AuthoritiesHow source document looks likePractical Demo of Safety DatabaseAdditional Guidance SessionsHow to prepare for PV Interview?How to find PV Job?Why PV is the best career choice?By completing this course, you will be more confident to face your interviews.Along with main course, we have also shared Practical demo of Safety database and Additional Guidance sessions on How to find Pharmacovigilance Job, How to prepare for Pharmacovigilance Interview and Why Pharmacovigilance is the best career choice.We hope you will find this course very helpful and you will land your dream job in PV very soon. Good Luck!!!

Overview
Section 1: Main Topics

Lecture 1 Introduction of this Course

Lecture 2 What is Pharmacovigilance

Lecture 3 History of Pharmacovigilance

Lecture 4 Objectives of Pharmacovigilance

Lecture 5 AE, ADR and Side Effects

Lecture 6 Event seriousness

Lecture 7 Causality Assessment

Lecture 8 Product Labels

Lecture 9 Case triage

Lecture 10 Minimum criteria for case validity

Lecture 11 Case Narrative

Lecture 12 Case submission timelines to Health Authority

Lecture 13 Dechallenge concept

Lecture 14 Rechallenge concept

Lecture 15 Sources of ICSR

Lecture 16 SUSAR and Its Importance

Lecture 17 Special situation scenarios

Lecture 18 Basics of MedDRA

Lecture 19 Basics of WHO Drug Dictionary

Lecture 20 Important Regulatory Health Authorities

Section 2: Practical Demo

Lecture 21 How Source Documents looks like

Lecture 22 Practical Demo of Safety Database

Section 3: Additional Guidance Sessions

Lecture 23 How to Prepare for PV Interview

Lecture 24 How to Find PV Job

Lecture 25 Why PV is the Best career choice

Section 4: What is Next?

Lecture 26 What to do after this training

Graduate or postgraduate degree in Pharmacy (e.g. B Pharm, M Pharm, M S Pharm, Pharm D),Graduate or postgraduate degree in Medicine (MBBS, MD, BAMS, BUMS, BHMS),Graduate or postgraduate degree in Life Sciences (BSc, MSc, PhD),Pharmacovigilance early experience candidates

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