Career Prospects
is potential opportunities and the growth prospects in the field of
pharmacovigilance are huge. The principal role of a pharmacovigilant
officer starts right from the start of preclinical studies and
continues even after post marketing of the drug as drugs are evaluated
for toxicity in a limited group of patients before marketing. He would
be responsible for the detection, assessment, understanding and
prevention of adverse effects or any other drug-related problem both
long term and short term side-effects of medicines; thereby improving
the safety of drugs
Learning Outcome
is course presents the essential elements of safety monitoring during
clinical trial and post marketing of the drug and upon completion of
this course a student should be competent to Understand and participate:
Regulatory aspects in Pharmacovigilance (USFDA; European, Canada, India)
Roles
and responsibilities of the marketing authorization holder : The role
of the Qualified Person Responsible for Pharmacovigilance and
contractual arrangements
Reporting
Requirements (Expedited Reporting Requirements in Post-authorization
Phase & Reporting requirements in special situations in the post
authorization phase)
Preparation of Annual Safety Reports and Periodic Safety Update Reports
Key differences in the Pharmacovigilance Regulatory Environments of various countries
Establishing a Pharmacovigilance Database and Signal Detection Tools : What needs to be taken into account
How to use MeDRA in Adverse Reaction Reporting and Data Analysis
Key Functionalities of the Adverse Event Systems (AERS, VAERS and MAUDE)
Quality System in Pharmacovigilance : Good Practices, SOPs, Preparation for Audits & Inspections
Diagnosis and Management of Adverse Drug Reactions
