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Course Content
Session 1: Introduction to Pharmacovigilance, history, background
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Pharmacovigilance – Introduction to the Course
02:03 -
Part 1: Introduction to Drug Discovery, Clinical Trials and Pharmacovigilance
17:16 -
Part 2: Understanding History, Background & Significance of Pharmacovigilance
10:09
Session 2: Significance of Pharmacovigilance, workflow of PV
Session 3: Aggregate safety reporting
Session 4: Signal Detection & Risk Management – Part1
Session 4: Signal Detection & Risk Management – Part2
Session 5: Adverse drug reaction
Session 6: Different types of reports and ICSRs
Session 7: Case processing overview (ICSR) Database basics
Session 8: Understanding MedDRA and other drug dictionaries
Session 9: Narrative writing
Session 10: Introduction to Pharma, Biotech & Medical Device Industries Bonus Topic Pharmacovigilance Job Interview
Additional Study Material
PV – Certification Exam
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About Course
Pharmacovigilance
Course Objective
Extensive knowledge with detailed understanding of basics imparted to equip you to work at any global Clinical research organizations (CROs) or Pharmaceutical companies or Pharmacovigilance service providers.
Understand the topic to gain the skills, knowledge and competencies of a right candidate for the
Pharmacovigilance sector.
Overview of practical aspects of Pharmacovigilance activities as per the global standards like safety reporting, medical evaluation, casualty assessment, expectedness assessment, case processing, narrative writing, MedDRA etc. to make a student industry ready.
Learn to appear the interview with confidence and grab the best deserved job based on your skillset.
Why attend this training?
Pharmacovigilance & Clinical research is rapidly growing industry globally with growth rate of more than 40% per year. Being a particular specialty, this sector requires trained and skilled workforce, with basic understanding of Clinical Research, Clinical Data Management & pharmacovigilance. This is why, over any unskilled candidates, they prefer them who already understands the basics of safety reporting & it’s impact. In a typical pharmacovigilance department or specialized pharmacovigilance company, there are several positions. Pharmacovigilance offers excellent growth prospects. Here are some of the positions a fresher can get selected for- Drug Safety Associate; Drug Safety Scientist; Aggregate Report Scientist; Pharmacovigilance associate; Safety report specialist etc.
What are the benefits of this course after college?
At the end of this course you’ll gain comprehensive knowledge to the pharmacovigilance basics, clinical research processes, drug development process, regulatory affairs, essential documentation, roles and responsibilities, ethics, monitoring, conduct and management of trials, extensive training on Pharmacovigilance (PV) related issues. In other words, the students taking this course will completely industry ready as freshers.
