Raphaëlle Leclere

Raphaëlle Leclere

Senior Pharmacovigilance Consultant and Scientific Writing

Key Knowledge Areas:

  • Local and EU QPPV (deputy)
  • Pharmacovigilance
  • Writing : DSURs, PSURs/PBRERs, RMPs, ATU/RTU dossier

Contact

Education

 

Raphaëlle is a pharmacist and completed her Pharmaceutical education at the University of Châtenay-Malabry, France (Thesis on “Evaluation in vitro of cytokine release by biologics: strategy, involvement in product development and risk assessment in humans”). She also attained a Master’s Degree in Human Toxicology, Risk assessment and Vigilance (2012).

 

About Raphaëlle

 

Her recent work has included:

  • Management and submission of individual case safety reports in the context of early access program, post-marketing authorisation and clinical studies
  • Writing of safety reports (DSUR, PBRER, RMP) and regulatory support for submission
  • Act as France and EU QPPV deputy
  • Pharmacovigilance audit
  • Writing of non-clinical toxicology summaries during marketing authorisation application
  • Preparation of dossiers for early access programme requests
    (including ATU cohort in France) 

Background/Previous experience

 

Raphaëlle started her professional career in 2012, at CiToxLAB France as Study Director in Preclinical Toxicology. She was responsible for conducting regulatory toxicology studies in accordance with Good Laboratory Practice (GLP). She supported the management of studies including protocol writing, analysis of study data, and development of study reports. Through this experience, Raphaëlle developed her expertise in preclinical toxicology, which also contributed to developing knowledge in quality, regulatory affairs, and project management.

 

After 3 years of experience in the pharmaceutical industry, Raphaëlle moved to consultancy and joined BlueReg in 2015. Raphaëlle has been involved in various projects in drug safety assisting start-ups to international companies.

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