Pharmacovigilance

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

18 Comments

  1. 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.

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