POS 3985
Status 5

Safety Scientist

Beschreibung: For one of our German Pharma clients in Hessen we are looking for freelance support as: Safety Scientist (M/F/*)
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  • DSUR, PBRER and pSUSAR preparation/ project management/ writing up
  • Literature review processes; be able to understand the publications and highlight potential signals or important efficacy information
  • Safety data review using Spotfire or other visualization tools at the clinical level and for integrated data
  • Use ArisG or other safety databases to generate CIOMS and/or review
  • Knowledge of general case processing and expedited reporting activities
  • Surveillance related project management activities (slide preparation for safety committees and boards, meeting minutes., etc)
  • Safety evaluation report writing by applying principles such as Bradford Hill criteria, CTCAE, etc.
  • Knowledge and experience of CIOMS, GVP, FDA and ICH guidelines
  • Understanding of AESI, CMEs, DMEs, and activities surrounding these topics
  • Project management activities
  • Other (such as submissions support, launch activities, etc.,)
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  • Start: asap // Duration: 9 months + // Capacity: full time (80% remote, 20% onsite)
  • 6 years experience in drug safety/ pharmacovigilance, including case review/ preocessing
  • Early and post-marketing experience
  • Working experience in a global environment
  • Experience with oncology drugs
  • Very good communication skills
  • Languages: English (business fluent), German is an advantage
Bemerkungen: WANTED: Safety Scientist (M/F/D). Please contact +49 89 18 90 99 849 oder Skills: English, FDA (USA: Food and Drug Administration), German, GVP (Good Pharmacovigilance Practices), Pharma
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Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: 9 months
Einsatzort: Hessen, Germany
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