Safety Scientist (m/w/d)

Job title: Safety Scientist (m/w/d)
Contract Type: Contract
Location: Darmstadt
Salary: Competitive
Reference: BH-132100
Contact Name: David Cabrera
Phone Number: 062139998598
Job Published: 19 days ago

Job Description

Your 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.,)
Your profile
  • 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
  • Communication; clearly express ideas/position
  • English business fluent

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