Presentation
I am a pharmacist (PharmD) and I have a University thesis in PharmacoEpidemiology (PhD). Afterwards, I worked during 15 years as a practitioner in the Regional Center of Pharmacovigilance (CRPV) of Toulouse before joining Universal Medica as Pharmacovigilance Manager (PV). During these 15 years, I carried out numerous appraisals for the ANSM, in particular in oncology.
What is your role as a Pharmacovigilance Manager?
As a Pharmacovigilance Manager, I am in charge of a pharmacovigilance and medical information team. We accompany laboratories with their needs in pharmacovigilance, nutrivigilance, cosmetovigilance or materiovigilance. We intervene in:
– Cases identification of unwanted effects or special situation of pharmacovigilance thanks to medical information, in literature (electronic databases, monitoring in non-indexed magazines) or in European Medicines Agency’s EudraVigilance database (L2A & medical literature monitoring requests).
– Cases handling: cases are seized or imported in every customer’s databases. Some must be submitted to EMA.
– Signal detection: collected cases allow us to identify the arisen of a pharmacovigilance signal. In the presence of a signal, we must assess and analyze the signal to determine if there is a risk. If the risk is validated, authorities must be informed.
– Safety reports writing: these reports, which integrate all administrative, commercial data, on profit and risk, must be transmitted to EMA.
What is the impact of the new pharmacovigilance regulations on your work?
Today, with the new features of EudraVigilance, laboratories have to import in their own databases, all the cases transmitted to the EudraVigilance base by authorities as the ANSM or by other pharmaceutical companies, if one of their drugs is considered suspect. That impacts on the volumetry of the cases to be handled for pharmaceutical companies.
Besides, the non-severe cases must now be submitted to EudraVigilance within 90 days.
A new feature of EudraVigilance is also in deployment process. It is EVDAS, a signal detection tool.
We trained our teams to anticipate these changes, to be able to bring our expertise and an operational support to our customers, adapted our processes and revised our quality documentation accordingly.
What is the added value of your position for the customer?
Our customers benefit from our expertise and from the entire team’s reactivity. They have one interlocutor to simplify the communication. Having personally worked for CRPV and for the ANSM, I have a good knowledge about how authorities function and what their expectations are. I am also responsible for making sure detected cases or reports submission are processed within the set deadlines. Lastly, this position allows me to lead various projects that improve pharmacovigilance practices for everybody.
Emmanuel B. Pharmacovigilance manager
