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Pharmacovigilance (Theory)

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.
  • 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/ Drug Safety theory :-

    • History and overview of Pharmacovigilance

    • Regulatory Authorities country wise

    • Pharmacovigilance in India

    • Spontaneous reporting

    • Active pharmacovigilance

    • Cohort Event Monitoring

    • Adverse Events and its types

    • Drug Safety in clinical trials and post marketed drugs

    • Different sources of Adverse Events reporting

    • Different types of AE Reporting Forms

    • Expedited reporting and its timelines

    • Aggregate reporting

    • Different departments working on Pharmacovigilance

    • Business workflow of Pharmacovigilance

    • Minimum criteria for the case

    • Causality assessment of the adverse event

    • Expectedness assessment of the adverse event

    • Seriousness assessment of the adverse event

    • MedDRA and WHODD coding

    • SAE narrative writing and Templates

    • PBRER/PSUR and its submission timelines

    • E2A-E2F Guidelines

    • PADAR

    • Explanation of Safety Signals, Signal Detection at UMC

    • Signal publication and communicating signal

    • Risk management

Projects

  • Pharmacovigilance Project

    We will provide Pv Realtime scenarios.

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

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.

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Keerthi

Pharmacovigilance Associate

I heard Covalent Trainings is the best institute for PV training in Hyderabad. After successfully finishing my PV course there, I would like to express my appreciation to the Gratisol Labs for all that you did to help me in to be a Pharmacovigilance Professional.

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Chandana B

Pharmacovigilance Associates

The best decision that I have ever taken at the beginning of my career is joining Covalent. Not only my skills were polished but my overall personality was groomed at Covalent.

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Golipally Bhavani Reddy

Drug Safety Associate

It was an amazing experience in Covalent Hyderabad. I would recommend to join if you have any interest in pharmacovigilance well experienced staff.

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SACHIN ANTIL

Fresher

I suggest all Pharmacy and Life Science Graduates to take up the training of Pharmacovigilance and secure good MNC Jobs in CRO's and IT Companies.

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