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VM - Délégués pharma/ hospitalier

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VM - Délégués pharma/ hospitalier

Date de dernière mise à jour :

13 avril 2015

Lieu :


CV :

Head of Pharmacovigilance and Regulatory Affairs departments
From Aug. 2011
LYSARC The Lymphoma Academic Research Organisation, Pierre-Bénite
o Relation with partners: negotiation, agreements, flow charts
o Contribution to study synopsis and protocol
o Assessment of SAEs and notification of SUSARs to EMA, Health Authorities, Ethics Committees, Investigators
o SOP development and implementation (IQ, OQ, and PQ validation of PV database)
o Medical Coding
o Regulatory support and guidance to project teams
Regulatory Affairs Pharmacist
Mar. 2010 – Jul. 2011
MSD France Merck & Co., Regulatory Affairs Department, Paris
o Expertise in both French and European registration procedures
o Obtained and maintained marketing authorizations, managed variations and renewals
o Kept updated with Regulatory Policy
o Validated labelling, leaflets and packaging component's artworks
Project manager
May – Aug. 2009
AFSSAPS French Health Care Products Safety Agency (now ANSM), Management of MA procedures and European Regulation Unit, Saint-Denis
o Monitored and coordinated the follow-up of the files for requests or modifications of MA according to national or European procedures
o Responsible for a file relating to lawful national mentions to include in MA granted by Agency
Pharmacovigilance officer
Jan. 2007 – Sep. 2008
GELARC Adult Lymphoma Study Group Clinical Research, Pierre Bénite
o Worked out the tolerance follow-up of products in development and marketed in order to guarantee patients' safety within the applicable legislation (reporting to authorities adverse events, writing annual safety reports)
Data manager
Sep. 2005 – Dec. 2006
GELARC Adult Lymphoma Study Group Clinical Research, Pierre Bénite
o Developed and managed clinical trial databases
o Controlled coherence and quality data

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