Global Drug Safety Consultant (m/f/d) – Freelance – on hold

  • Position zu besetzen ab 17. Juni 2019
  • Permanent-ID OCR-FL-719
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Tasks

  • Support TMF activities for company sponsored (Cladribine Studies) phase I to IV
  • Review of safety sections of study related documents (e.g. Clinical Trial Protocol, Drug Safety Manual/Safety Processing Plan, Trial Oversight Plan, SAE reconciliation plan, Trial Oversight Plan) including documents for Cladribine IST studies
  • Communication of clinical studies within GPS (e.g. clinical study status)
  • Contribute to defining and implementing of clinical trial safety-related activities in the alliance with relevant partners/service providers and alignment of guidelines and processes related to clinical trial safety management with existing GPS processes
  • Support post-Marketing activities (e.g. Global Literature Surveillance)

Skills

  • Experience in alignment of guidelines and processes related to clinical trial safety management with existing GPS processes > 5 yrs.
  • Experience in creating documents for Cladribine studies > 5 yrs.
  • Experience in defining and implementing of clinical trial safety related activities > 5 yrs.
  • Experience in review of safety sections of study related documents (e. g. Clinical Trial Protocol, Drug Safety Manual/Safety Processing Plan) > 5 yrs.
  • Experience in supporting TMF (Trial Master File) activities (Cladribine studies) phase I to IV > 5 yrs.
  • Knowledge with post-marketing activities (e.g. Global Literature Surveillance), nice to have
  • Languages: English & German business fluent

Additional Information

  • Location: Darmstadt
  • Project start: 17.06.2019
  • Duration: 6 months
  • Availability: fulltime on site
  • Remote: tbd.

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