Connecting

Safety Scientist (m/w/d)

Job title: Safety Scientist (m/w/d)
Contract Type: Contract
Location: Darmstadt
Industry:
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

Get similar jobs like these by email

By submitting your details you agree to our T&C's

Share this Job

The spread of COVID-19 is affecting all of us. But as a global staffing company, NES would like to reassure our customers that we are fully operational across all our locations and are working closely with clients to ensure essential projects stay on track at this difficult time. For regular updates, please see our COVID-19 Support Hub.