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Quesite ICon

Pharmacovigilance

Pharmacovigilance also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

3000+

Students Trained so far

Placement

Oriented Curriculum

45 Hrs

Instructor Led Program

1

Industrial Case Studies

Customized Tracks For Better Results

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Module I, II, III

You will be introduced to pharmacovigilance, Historical overview, Principles and methodologies.

Regulations, Policies and Advrse drug reactions and safety reports.

ADR Reporting and many more

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Module VI, V, VI

In this three modules, Participant will be learning about signal analysis.

compilance to clinical safety and pharmacovigilance regulations.

Pharmcovigilance management and importance.

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Career Advancement Support Plus

By the end of the program, we will assist students to design their persona and resume required to represent them self in industry and will help them in connecting them with right jobs through regular notifications.

Program Overview

Key Features

Top skills you will learn

Participant will be undergoing 6 modules which covers case studies and all the concepts of pharmacovigilance.

Job Opportunities

After completing the course you will be getting placement assistance and completing the mock interviews scheduled by the instructor.

Who can enroll for this programs ?

Students or Freshers from Pharma background looking to up-skill and become industry ready with the help of our verified instructors.

Eligibility Criteria

Student or fresher pursuing his/her career in the domain of pharma and medicine.

Our Process

Training

Co-Working

Assessment

Reult

Certification

Syllabus & Modules

Our curriculum suits the requirement of the industry

Pharmacovigilance

  • Introduction
  • Historical Overview
  • Basic principles of Pharmacovigilance in Clinical Trials
  • Methodologies for Pharmacovigilance

Regulations in Pharmacovigilance in Clinical Research

  • FDA and EU perspectives
  • Drug Regulatory Activities MedDRA
  • Regulatory Aspects in Pharmacovigilance
  • EudraVigilance
  • Regulations in Pharmacovigilance in Clinical Research

Adverse Drug Reactions and Safety Reports

  • ADR Reporting
  • Causality Assessment of Suspected Adverse Drugs Reactions
  • Periodic Safety Update Reports (PSURs) For Marketed Drugs (ICH E2C)
  • Expedited Reporting Requirements
  • Individual case safety reports
  • Periodic safety update reports
  • Electronic safety reporting
  • WHO & safety monitoring

Signal Analysis

  • Definition of signal and type of signal
  • Conducting signal detection in clinical and post marketing surveillance
  • Defining signal in relation to risk/benefit
  • Signal generation to decision making
  • Signal Detection Tools
  • Understanding signals & benefit risk determinations

Intro to Compliance to Clinical Safety and Pharmacovigilance Regulations

  • Review of benefit-risk assessments and management
  • Scope of Pharmacovigilance inspection and conduct of inspection
  • Internal audit of pharmacovigilance activities of a company
  • Pharmacovigilance inspection reports
  • Pharmacovigilance compliance and inspection
  • Quality System in Pharmacovigilance : Good Practices, SOPs, Preparation for Audits & Inspections
  • Scope of Pharmacovigilance inspection and conduct of inspection
  • Internal audit of pharmacovigilance activities of a company
  • Key Functionalities of the Adverse Event Systems

Intro to Pharmacovigilance Management and Importance

  • Pharmacovigilance Database
  • Setting up a Pharmacovigilance Centre in Industry
  • Management of Pharmacovigilance Data
  • Risk Management in Pharmacovigilance
  • Data management & software solutions
  • Effective communication in pharmacovigilance
  • Pharmacovigilance in special situations
  • Pharmacovigilance capacity building
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What Our Students Have to Say

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In the stage of not knowing what to do, I found the Android Development program at Quesite. This program gave me a kick start for my career in android development.
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Student - Android Development

Meet Our Instructor

Mr. Kiran Analytical and results-orientated associate with more than 7 years’ experience having special focus on Pharmacovigilance, Data Analytics, Quality and Compliance. Received  University top rank in M.Pharm (Pharmaceutics) University top rank in B.Pharm for the academic.

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