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Looking for safety expert

  • Regulatory services - CMC writing - medical writing, Consulting - strategy and development
  • Human Medicines
  • Europe
  • 10/13/2012

Description

We are looking for a safety expert. Provision of specific strategic safety input - e.g. how to present a specific safety concern in the CO/RMP/REMS. Advise in regard to the classification of specific important identified / potential risks and how they are presented in the RMP in sections "Additional PV activities" / "Risk minimisation measures"
Review of ISS, SCS, CO, RMP (REMS ? ) or at least parts of the documents.

Requirements

  • EMA experience
  • FDA experience

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