Pharmacovigilance – Guidance material

Pharmacovigilance (PhV or PV) is a pharmacological science, also known as reliability in drugs, which plays a key role in the healthcare system through the collection, detection, evaluation and avoidance of negative drug-related impacts. This is a database, in other words. This is the ICSR database and the software used in the PV world to enter these cases.

To perform these actions there are certain guidelines which we must follow and having a training or reading through these guidelines is useful for the one who is looking their career in pharmacovigilance.

Though pharmacovigilance is an inseparable part of drug, training in this area is almost non-existent in medical schools, nursing schools and other medical professional schools. Only schools of pharmacy seem to have any sort of training and even there it is still largely undeveloped.

In the past getting training in Drug Safety (DS) and Pharmacovigilance (PV) was very difficult. Most of it involved on the job training in the company or health agency where you worked. But currently there are many organisations offering trainings on Pharmacovigilance with course duration of few days to months. But please do note that there are no certificates or degrees that are yet universally accepted as credentials for employment in Drug safety or Pharmacovigilance. Although a degree or certificate is certainly useful and praiseworthy, it is not clear that this will get you a job or necessarily enhance your ability to get a position. 

Below you can find pharmacovigilance training material which is prepared from understanding of Good Pharmacovigilance practices, EMEA guidelines, FDA guidelines, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), WHO – UMC, The Council for International Organizations of Medical Science (CIOMS) and from personal experience gained from pharmacovigilance industry.

  1. ICSR processing, aggregate reporting and Signal management
  2. Vaccine Vigilance
  3. Medical device vigilance
  4. Cosmetovigilance
  5. Quality Management system
  6. Pharmacovigilance of Health supplements

Contact us:

Mail: allaboutpv.training@gmail.com

Comments

18 responses to “Pharmacovigilance – Guidance material”

  1.  Avatar
    Anonymous

    Thank you for material.. it is very informative and useful..

  2.  Avatar
    Anonymous

    Thank you for this πŸ™‚

  3.  Avatar
    Anonymous

    Excellent

    1. Ramya Avatar
      Ramya

      Thank you

      1.  Avatar
        Anonymous

        Brilliant ! Very Useful

  4. Kumudha Avatar
    Kumudha

    Excellent
    Easy to understand and Very useful
    Thank you so much for your efforts to do thisπŸ™‚

    1. Ramya Avatar
      Ramya

      Happy to hear that πŸ™‚

  5. Ankush Chauhan Avatar
    Ankush Chauhan

    Very informative..much appreciated πŸ‘

  6. Swathi Vasu Avatar
    Swathi Vasu

    Easy to understand and very informative thank you so much ramya

  7. Adam Golightly Avatar

    I can understand how a business could really benefit from getting some more guidance and they can be sure to practice more safety. It could be really useful for a business to ensure that they can have the right procedures and safety so that they have the right training. It was interesting to learn about how drug safety and pharmacovigilance can be hard to get training in and a degree could be useful for them to get a better job.

  8.  Avatar
    Anonymous

    Very Informative and interesting !!

  9.  Avatar
    Anonymous

    Very nice.. everything about Pharmacovigilance at one place .. much appreciated for your efforts.

  10.  Avatar
    Anonymous

    This is a very informative material thank you

    1. Ramya Avatar
      Ramya

      Thank you

  11. KANDARP PATEL Avatar
    KANDARP PATEL

    What a Fantabulous job you have done !! Kudos to your efforts and Huge shoutout to you…Ramya πŸ™‚ Thank you so much on behalf of whole PV world πŸ™

  12. KANDARP PATEL Avatar
    KANDARP PATEL

    What a fantabulous job you have done !! Kudos to your efforts and huge shoutout to you πŸ‘ Thank you so much on behalf of the whole PV world , Ramya πŸ™

  13.  Avatar
    Anonymous

    Thank you so much for the material. Do you also provide 1-on-1 training? If so, please let me know at rx1.student@gmail.com

    1. Ramya Avatar
      Ramya

      Please email to allaboutpv.training@gmail.com

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