"It was a wonderful experience interacting with you and appreciate the way you have planned and executed the whole publication process within the agreed timelines.”
Subrat SaurabhAuthor of Kuch Woh Pal
Pharmacovigilance Made Easy is a compilation of all the material which is essential to understand and practice the concepts of Pharmacovigilance and Patient Safety for Freshers who wish to swim on the surface as well as for Experienced Professionals who wishes to dive deeper It also contains a compilation of the most frequently asked interview questions in the domain of Pharmacovigilance.
This book intends to provide you all the information that you need to crack the Pharmacovigilance interview by providing you basic understanding of the concepts such as:
Introduction, History and Overview of Pharmacovigilance
Drug Development and Clinical Trial Phases
Pharmacovigilance Process Life cycle
Introduction and responsibilities USFDA EMA and CDSCO
Clinical Development process
Different phases of clinical Trials
Adverse events and its types
Drug Safety in clinical trials and post marketed drugs
Different sources of Adverse events reporting
Different types of AE reporting Forms
Expedited reporting and its timelines
Different departments working on Pharmacovigilance
Roles and responsibilities of case receipt unit
Roles and responsibilities of Triage unit
Seriousness criteria of adverse event
Expectedness or Listedness of adverse event
Causality assessment of the adverse event
Narrative writing
Case quality check Medical review and its submission
Aggregate reporting Overview
Signal Management Overview many more
Gopala Krishna Varshith
A Health-Tech Nerd and a Polymath, around 3+ years of experience and expertise in the areas of Pharmaceutical Drug Safety Operations, Patient Safety, Medical Content Writing, Marketing, Customer Delight, Planning & Strategy, Branding and Design with a Master's in Pharmacology.
Being worked in Pharmaceutical Patient & Drug Operations for various Contract Research Organisations for more than 18 months in various projects including biologics, vaccines, immunologics etc, the author has accrued decent knowledge in the field in practical as well as theoritical aspects of Pharmacovigilance.
