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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. The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation.

Why this course ?

The information collected during the pre-marketing phase of a medical drug is inevitably incomplete with regard to possible adverse reactions, Pharmacovigilance is needed in every country, because there are differences between countries in the occurrence of adverse drug reactions and other drug-related problems.

Course Features

  • Instructor Live Sessions

    There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
  • Real-time Case Studies

    Live project based on any of the selected use cases on the above selected Domain. 
  • Assignments

    Each class will be followed by practical assignments which can be completed before the next class.
  • Lifetime Access

    You can get lifetime availability of class recordings and presentations can be shared with you, you can download and Stored in your system.
  • 24 x 7 Expert Support

    We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
  • Certification

    Towards the end of the course, you will be working on a project. Covalent certifies you as an course Expert based on the project.

Course Curriculum

Download
  • Pharmacovigilance

    Pharmacovigilance:-

    Module I Pharmacovigilance

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

    Module II 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

    Module III 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

    Module IV 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

    Module V 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
    • Quality System in Pharmacovigilance : Good Practices, SOPs, Preparation for Audits & Inspections

    Module VI 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

     

    HR-Interview Etiquettes:-

    • Communication Skill
    • Office etiquettes
    • E-mail etiquettes
    • Presentation skills and Public speaking
    • Interview preparation
    • CV preparation
    • Mock interviews
    • Assessments

Projects

  • Pharmacovigilance Project

    Pharmacovigilance Real time projects

FAQ's

  • Can I attend a demo session before enrolment?

    Yes

  • What if I miss a class ?

    If you miss a class we can give backup calss for particular session and same session you have to attend another batch also

  • Will I get placement Assistance ?

    Yes

  • Do I receive a certificate for training ?

    • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
    • Covalent certification has industry recognition and we are the preferred training partner for many MNCs.
  • what support is available after the training?

    Doubts clarification up to getting a job

    Resume preparation

    Mock interviews

    Placement Assistance

  • What Features do you provide?

    1. clasroom & online sessions
    2. Real time case studies
    3. Working faculties (industry experts)
    4. Assignments
    5. Software Handson experience
    6. Corporate training with industry exports
    7. Placement assistance
    8. Resume preparation
    9. Doubts

Certifications

  • Course Completion Certificate

    • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
    • Covalent certification has industry recognition and we are the preferred training partner for many MNCs.

Videos

Videos

Reviews

Reeta Prajapathi

Drug Safety Associate

I want to thank Covalent for their support. After completion of my B.Pharm(2017), I have joined Covalent for SAS Clinical and PV Training for 3 Months program. After completion of training with in a month duration I got placed in TCS in Pharmacovigilance Department.

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Vikash Reddy G

Drug Safety Associate

I am very glad to inform you that I got an opportunity with TCS, Mumbai Location. Covalent has helped me in achieving my goal. It has given me a perfect foundation in Pharmacovigilance for my success. This is the best place for freshers who want to achieve Jobs in Pharmacovigilance in IT & Pharma Industries.

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Prathiba Chitra

MBBS, DSP

I am greatful to Covalent, which provided me best guidance in opting the best course for better career after completion of my MBBS and today I am associated with Quintiles, Banagalore.

readmore...

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