About Fatime
English
Fluent
French
Native or bilingual
Korean
Basic
Experience
- SanofiMedical Affairs ManagerPHARMACEUTICALS INDUSTRYSeptember 2018 - March 2020 (1 year and 6 months)Gentilly, France- Organization and coordination of medical activities for participation in medical and scientific congresses: submission of abstracts, preparation of communications (posters...) and symposium- Participation in the monitoring of the publication plan (manuscripts, abstracts, posters)- Preparation and participation in medical boards- Scientific & bibliographic monitoring: data analysis- Creation of medical content for medical and scientific communication- Monitoring of publications- Monitoring of clinical trials- KOLs management- Creation and review of medical content (internal and external presentations, training book...)
- Hospices Civils de LyonClinical Research AssociateMEDICALJanuary 2018 - August 2018 (8 months)Lyon, FranceManagement of 3 industrial studies and 2 institutional studies:- Regulatory submissions (CPP, CNIL, ANSM), submissions to calls for tenders (PHRC…)- Writing and review of study documents (protocol, consent, CRF, SOP)- Management of study drugs and biological samples- Operational meetings with investigating physicians and the project team- Presentation of the study to the hospital medical team and/or patients- Selection / inclusion / monitoring of patients- Pharmacovigilance (reporting of adverse effects)
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Education
- Master 2 clinical evaluationInstitut de pharmacie industrielle de Lyon (IPIL)2019Faire acquérir la méthodologie d'évaluation et les connaissances nécessaires pour concevoir et mettre en œuvre les stratégies de développement, l'usage correct, la réglementation, le suivi du produit de santé à usage humain après sa mise sur le marché
- Clinical Research Associate CertificateSup Santé2018PROGRAMME : - Bloc 1 : Initier une étude clinique - Bloc 2 : Contrôler la Qualité d’une étude clinique - Bloc 3 : Réaliser et gérer la documentation d’une étude clinique - Bloc 4 : Soumettre les dossiers réglementaires aux autorités compétentes - Bloc 5 : Contrôler la Pharmacovigilance d’une étude clinique - Bloc 6 : Mobiliser les apports des connaissances du champ médical relatives aux études cliniques
Certifications
- ICH Good clinical Practice E6 (R2)Transcelerate biopharmac Inc2018
Skill set
Categories
- Other