ID EXISTS
POS 4179
Status 5
DJM 1

Pharmacovigilance Consultant - Safety Scientist

Beschreibung: For one of our Pharma-clients in Hessen we are seeking freelance support as: Pharmacovigilance Consultant - Safety Scientist (M/W/D)
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Tasks:
  • 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 tool at 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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Qualification:
  • Start: asap, latest 15.01.2021 // Duration: 8-12 months // Capacity: full-time remote
  • At least 6 years in drug safety/pharmacovigilance, including experience with case review/processing
  • Early and post-marketing experience
  • Working experience in a Global environment
  • Experience with oncology drugs welcome
  • Collaborative personality and good communication skills; should clearly express ideas/position
  • Business fluent in English
  • Nice to have: German
Bemerkungen: WANTED: Pharmacovigilance Consultant - Safety Scientist (M/F/D). Please contact +49 89 18 90 99 606 or celina.sattler@k-recruiting.com Skills: English, FDA (USA: Food and Drug Administration), German, GVP (Good Pharmacovigilance Practices)
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Interesse geweckt?
Auf geht's!
Beginn: asap, latest 15.01.2021
Laufzeit: 8-12 months
Einsatzort: Hessen, Germany
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