| Even large pharmaceutical companies struggle to find | | | | processing them, expediting them where necessary, |
| suitable expertise in-house. Running a search in Google | | | | adding them to the pharmacovigilance database, |
| for "pharmacovigilance job" will show you just how | | | | dealing with and liaising with medical professionals and |
| desperate the shortage it. This shortage of talent | | | | regulatory bodies on your behalf and also taking calls |
| brings consequent problems when they are inspected | | | | and queries from members of the public. Remember, |
| by the competent authorities, such inspections being | | | | when any member of your company or the |
| an inevitable part of the pharmacovigilance process. | | | | company acting on your behalf hears of a potentially |
| The demands on medium and small companies are | | | | serious adverse reaction, they have 15 days to get |
| such that they can not comply economically in-house | | | | that report confirmed and submitted to the regulator. |
| and must outsource parts or all of their | | | | Outsourcing is a serious matter. Your marketing |
| pharmacovigilance and drug safety operations. They | | | | authorization depends on it. What steps are you |
| are then left trying to find a reliable pharmacovigilance | | | | taking to make sure that your pharmacovigilance |
| resource that they can trust. | | | | outsourcing is validated and compliant? Is your |
| For small and medium-sized pharmaceutical companies | | | | qualified person available at all times when they need |
| the cost of running a pharmacovigilance system is | | | | to be? Are they experienced in responding to queries |
| prohibitive - they simply can't afford to do it, | | | | from regulators? |
| however worthwhile and important it might be. For | | | | There are many companies out there offering |
| larger companies pharmacovigilance systems may be | | | | pharmacovigilance services but very few that have |
| something that they would wish to outsource for | | | | been set up as dedicated pharmacovigilance contract |
| reasons of efficiency. There are a number of | | | | research organizations by some of the people who |
| contract organizations who can run your | | | | have been in the industry since the start. |
| pharmacovigilance system for you. Again there are | | | | PrimeVigilance were established as a joint venture |
| many factors to consider, cost being just one of | | | | between Ergomed, a CRO, and Elliot Brown |
| them. | | | | Consulting whose managing director was one of the |
| With an outsourced pharmacovigilance system, the | | | | authors of MedDRA the Medical Dictionary for |
| regulator will consider you liable for any problems | | | | Regulatory Authorities, now used worldwide by all |
| rather than the company you contract to, so you will | | | | regulators, pharmaceutical companies and most |
| want to make sure that the staff are properly | | | | recently the WHO. A similar consultancy service is |
| trained and fluent in the relevant languages that they | | | | offered by Pietrek Associates. The other option is to |
| will need, most predominantly English. They will be | | | | go with one of the big CROs such as Parexel, but |
| taking in reports from medical professionals and | | | | costs with companies such as this can be prohibitive. |