Main tasksset up and handle the local PV system;assure on the French soil:• control of the entire PV system in France;• compliance with its obligations regarding PV, in particular:o reporting of adverse events, transmission of PSURs;o implementation of the RMP;o implementation and update of the measures described in the EU RMP at national level and specific measures on the national territory requested by the ANSM, such as enhanced surveillance or reduction activities, as well as monitor the results of the risk reduction measures;o implementation of the conditions imposed by the MA, in particular the implementation and monitoring of post-MA safety studies;• any request from the ANSM and/or the CRPV & CEIP-A, aimed at obtaining additional information necessary for the exercise of PV, be followed by a complete answer within the given time;implement the necessary measures for the detection and validation of signals and cooperate in the evaluation of a confirmed signal in accordance with the modalities described in Module IX of the GVP including the estimation of the incidence of suspected adverse reactions (or otherwise the rate of notifications);have elements guaranteeing the control of the computerized systems used in the context of the performance of PV activities, their validation and their maintenance in the validated state;act as the primary contact person for safety issues for the French CA & the EU-QPPV on a 24h basis;inform the EU-QPPV of a local Health Authorities inspection request;inform the EU-QPPV of any request from the local Health Authorities for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product, and for the response related to sales volume or prescription of the medicinal products;review of PVA at local level;inform the EU-QPPV of any local regulatory requirements of any information that could affect the PV System;safety review of PQC;PV training

- Contacting vets and pet owners for documenting pharmacovigilance cases- Entering cases in PV-Works database and causality assessment- Medicolegal investigation coordination- Involvement in audits and/or inspections- Literature screening- PSURs transmission to the NCA - Responses to the NCA- Pharmacovigilance and Quality training- Involvment in quality system maintenance- Publicity control- Lot surveillance -Exploitant Compliance

Global Pharmacovigilance Drug safety officer (Neuropsychiatry department)- Safety data processing, coding (MedDRA) and narrative writing of individual case reports- Managing safety information from different sources (spontaneous reports, literature searches, clinical trials…) : assessment of Individual Case Safety Reports (ICSR) on seriousness, causality, expectedness - Regulatory assessment and respect of timeframes defined by regulation and procedures.- Evaluation of safety signal detection - Elaboration and update of the SmPC and patients’ leaflets in collaboration with Regulatory Affairs - Coordination and writing of periodic safety reports: PSUR, Risk Management Plan, DSUR- Responses to Regulatory Authorities- Involvement in clinical project teams- Preparation and participation in audits and inspections conducted by EMA/ANSM- Expert committee cases presentation- Literature monitoring- Training of PV auditors and newly arrived colleagues on procedures- Telephone support stand-by for health care professional and patient (Medical Information, Pharmacovigilance)

• Involvement in the crisis unit set up for Mediator• Management and documentation of french post marketing PV cases (Health Authorities, health care professionals, patients, Post Authorization Safety Studies) including assessment of expectedness and seriousness, narrative writing, follow up of cases, reconciliation with medical information and quality department• Medical review of Pharmacovigilance cases; Phone stand-by duty for PV and medical information • Complaints management with Legal Department• PV trainings of internal staff, distributors and partners (face trainings, webinars, eLearning)• Support during documentation of worldwide Pharmacovigilance cases• Creation of documentation tools in collaboration with medical Experts

Chemical submission database management and police case reviewPoison Center Tasks (phone answering, case documenting, literature research)Collection and assessment of Addictovigilance casesPharmacodependance

Extern Pharmacist Trainee in HepatoGastroEnterology Department in Purpan Hospital and in Claudius Regaud Cancer Center.

Cutaneous Biology and Dermocosmetology Course Unit