Pharmacovigilance

Categories: Free for Nerd Members
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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.

What Will You Learn?

  • Learn from Industry expert
  • Get end to end knowledge on PV

Course Content

Session 1: Introduction to Pharmacovigilance, history, background

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

PV – Certification Exam

Additional Study Material