Pharmacovigilance Made Easy: - A Compilation

<p><b>Pharmacovigilance Made Easy</b> 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.<br/> <br/> 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:</p><p>Introduction History and Overview of Pharmacovigilance<br/>Drug Development and Clinical Trial Phases<br/>Pharmacovigilance Process Life cycle<br/>Introduction and responsibilities USFDA EMA and CDSCO<br/>Clinical Development process<br/>Different phases of clinical Trials<br/>Adverse events and its types<br/>Drug Safety in clinical trials and post marketed drugs<br/>Different sources of Adverse events reporting<br/>Different types of AE reporting Forms<br/>Expedited reporting and its timelines<br/>Different departments working on Pharmacovigilance<br/>Roles and responsibilities of case receipt unit<br/>Roles and responsibilities of Triage unit<br/>Seriousness criteria of adverse event<br/>Expectedness or Listedness of adverse event<br/>Causality assessment of the adverse event<br/>Narrative writing<br/>Case quality check Medical review and its submission<br/>Aggregate reporting Overview<br/>Signal Management Overview many more</p>