Certificate Course in Pharmacovigilance ICSR Case processing
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
- Basic level of English
- Good quality of Internet connection
- Desktop, Laptop or Smartphone
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
Minimum criteria for case validity
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!!!
Who this course is for:
- 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
We are here to help students from Pharma, Life sciences and Medical doctors to train them on Pharmacovigilance domain and make them job ready.
Our PV faculty have more than 10 years of Pharmacovigilance Industry Experience and in-depth knowledge of ICSR, Aggregate Reports, Signal and Risk Management.
We are sure that after you take these trainings, you will be more confident to face PV Interviews.