A Pharmacovigilance Course for Beginners by PV Drug Safety Academy
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.
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.
Course Content
- Main Topics –> 20 lectures • 1hr 53min.
- Practical Demo –> 2 lectures • 23min.
- Additional Guidance Sessions –> 3 lectures • 25min.
- What is Next? –> 1 lecture • 2min.
Requirements
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 course
- What is Pharmacovigilance
- History of Pharmacovigilance
- Objectives of Pharmacovigilance
- AE, ADR and Side Effects
- Event seriousness
- Causality Assessment
- Labelling
- Minimum criteria for case validity
- Case triage
- Case Narrative
- Case submission timelines to regulatory authority
- Dechallenge/ Rechallenge concept
- Sources of ICSR
- SUSAR and Its Importance
- Special situation scenarios
- Basics of MedDRA
- Basics of WHO Drug Dictionary
- Important regulatory Authorities
- How source document looks like
- Practical Demo of Safety Database
- Additional Guidance Sessions
- How 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!!!