For small and medium-sized pharmaceutical companies the cost of running a pharmacovigilance system is prohibitive – they simply can’t afford to do it, however worthwhile and important it might be. For larger companies pharmacovigilance systems may be something that they would wish to outsource for reasons of efficiency. There are a number of contract organizations who can run your pharmacovigilance system for you. Again there are many factors to consider, cost being just one of them.
With an outsourced pharmacovigilance Pharmacovigilance course system, the regulator will consider you liable for any problems rather than the company you contract to, so you will want to make sure that the staff are properly trained and fluent in the relevant languages that they will need, most predominantly English. They will be taking in reports from medical professionals and processing them, expediting them where necessary, adding them to the pharmacovigilance database, dealing with and liaising with medical professionals and regulatory bodies on your behalf and also taking calls and queries from members of the public. Remember, when any member of your company or the company acting on your behalf hears of a potentially serious adverse reaction, they have 15 days to get that report confirmed and submitted to the regulator. Outsourcing is a serious matter. Your marketing authorization depends on it. What steps are you taking to make sure that your pharmacovigilance outsourcing is validated and compliant? Is your qualified person available at all times when they need to be? Are they experienced in responding to queries from regulators?
pharmacovigilance contract research organizations by some of the people who have been in the industry since the start. PrimeVigilance were established as a joint venture between Ergomed, a CRO, and Elliot Brown Consulting whose managing director was one of the authors of MedDRA the Medical Dictionary for Regulatory Authorities, now used worldwide by all regulators, pharmaceutical companies and most recently the WHO. A similar consultancy service is offered by Pietrek Associates. The other option is to go with one of the big CROs such as Parexel, but costs with companies such as this can be prohibitive.4