Shimsi LEFKI

En résumé

Entreprises

• Orphan - Medical Information Manager

  2015 - maintenant * Develop and execute up-to-date, accurate, timely and appropriate verbal or written responses to unsolicited inquiries escalated through internal and external channels. ;
  * Set up and maintain the tracking medical information requests. ;
  * Review, create, maintain medical information document expertise by ensuring that responses are medically and scientifically accurate, timely, fair, and meet customers' needs ;
  * Support Medical Dpt for medical questions

• Orphan Europe - International Project Leader

  2015 - maintenant * Coordinate with CMC and preclinical department in Recordati and other departments in OE ;
  * Support the medical director and the project team leader for medical research and new projects ;
  * Support the biometry department and Pharmacovigilance for medical questions ;
  * Draft the clinical parts for the clinical study (IB, summaries for questions)
  * Management of CRO for registry and clinical study ;
  * Write clinical report for the registry
  * Follow up the budget of clinical study ,

• Laboratoires Bouchara-Recordati - International Project Leader

  2011 - 2014 Collaboration with HQ preclinical department (Overactive Bladder, Phase II) ;
  - Pharmacovigilance support (medical review) ;
  - Coordination of clinical trials: Phase II and II including the selection of the third-part services
  - Drafting synopsis, protocols, inform consent form, Newsletter, Project Management Plan
  - Follow-up of the study budget ;
  - Communication and scientific support: realisation of posters ;
  - Organisation of Investigator's meetings ;
  - Drafting new procedures and processes for leading clinical projects in LBR

• SGS Life Science Services - Clinical Research Physician

  Arcueil 2009 - 2011 Drafting protocols and regulatory documents (Inform consent form, investigator brochure)
  - Conducting meetings for implementing strategy for clinical development plans for new drugs/existing products for extension indication to obtain new marketing authorization
  - Leadership to maintain contact with KOLs
  - Validation of the scientific contents ;
  - Preparing and managing the budget ;
  - Implementation of the clinical trials ;
  - Writing clinical study report

• Biotrial - Deputy Manager of clinical pharmacology Unit

  Rennes 2006 - 2006 Management of the staff (10 collaborators) ;
  - Implementation of the clinical studies in the unit ;
  - Leading meetings to present studies, to follow up and to present studies results

• Biotrial - Clinical Research Physician

  Rennes 2004 - 2004 Management of studies of bioequivalence, biodisponibility, pharmacokinetic, pharmacodynamics, single dosing studies and repeated dosing, food interaction, interaction with oestroprogestatif, interaction with the digoxin, interaction with an enzymatic inductive inhibitor, QT/QTc

• Biotrial Clinical Research Organization - Clinical Research Physician

  2004 - 2009

• FOVEA Clinical Research Organization - Clinical Research Coordinator

  2001 - 2004 *Clinical Research Coordinator and Medical Advisor
  -Implementation and follow-up of national and international clinical studies phases III and IV
  -Management of the budgets and supervising the partners
  -Leading meetings for studies set up and results presentation
  -Coaching and training of clinical research assistants ;
  -Coordination of therapeutic tests of phases III / IV and pharmaco-epidemiologic studies
  -Biometry support (AE/SAE/treatments coding)
  
  
  
  THERAPEUTICAL AREAS AND REFERENCES
  
  * Hepatitis C / Schering-Plough Laboratories pharmacoepidemiologic study
  * High Blood Pressure / Takeda Laboratory pharmacoepidemiologic study
  * Gynaecology / Hormonal Replacement Treatment pharmacoepidemiologic study
  
  * Burns Device: clinical trial of phase III
  * Dermatology and esthetic surgery ;
  *Addiction: Drug abuse / Bouchara-Recordati Laboratory Phase II

Formations

• Université PARIS VI

  Université Paris Diderot 1999 - 2000 Graduate Certificate

• FACULTE DE MEDECINE D'ALGER (Alger)

  Alger 1990 - 1999 Doctoral Degree
  
  * F.I.E.C. Diploma, (Drug's Clinical Trial Investigator Training)
  Paris VI University
  
  * Graduate Certificate in Clinical and Therapeutic Synthesis
  Paris VI - Pitié-Salpêtrière Medicine faculty

Réseau

Pas de contact professionnel