Within the current context of increasingly stringent regulations concerning health products, VIGIPHARM already helps many pharmaceutical companies to define and implement health vigilance strategies, either fully or partially.

VIGIPHARM has a team of pharmacovigilance experts, toxicologists and cosmetologists, physicians trained in dermatology, oncology and clinical trials, as well as data input operators and data base managers.

After having worked for several years In Regional Pharmacovigilance Centers in Paris and Montpellier, Caroline Navarre, Pharm D and senior pharmacovigilance expert, set up VIGIPHARM. The business has developed gradually over the years, working with increasing numbers of customers in the pharmaceutical industry.

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Public and professional bodies such as the French Health Authorities (AFSSAPS), the French National Agency for Veterinary Medicine (ANMV), the French National Agency for food, environmental and occupational health safety (ANAES), the European Medicines Agency (EMA) ask laboratories to set up a vigilance system, whatever their field of interest.

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Our keyboard operators can enter data and manage cases in the data base. We can determine imputability and the expected/unexpected nature of events, write case narratives and make decisions as to whether to inform the authorities. We can also transfer these cases electronically.
We can translate case narratives – from French, Italian and Spanish into English. We can code adverse events according the five level hierarchy of the MedDRA dictionary.

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Caroline Navarre has been working in health vigilance for over 15 years. She has a Master’s degree in pharmacovigilance, a university diploma in toxicology and post-graduate studies in statistics applied to medicine. She is certified by Eudravigilance for electronic transfer and by the MSSO (maintenance and support services organization) for MedDRA coding.

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