Safety Scientist (m/f/d) – Freelance – on hold

  • Position zu besetzen ab 13. Juli 2020
  • Permanent-ID OCR-FL-1031
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

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.,)

Skills

  • 6 years in drug safety/pharmacovigilance, including experience with case review/processing.
  • Early and post-marketing experience.
  • Work experience in a global environment
  • Experience with oncology drugs is a plus

Additional Information

Location: remote/Darmstadt

Project start: 13.07.2020

Duration: approx. 12 month

Availability: 4-5 days/week

On-site: 20%

Remote: 80%

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