Scientist, Drug Safety (fixed Term)

Laboratory Animal Management Association

Cundinamarca, , Colombia
Safety reporting in clinical trials
Individual case safety reports
Gcp and ich regulations
The Scientist Level Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late-stage development

Job Summary

  • The Scientist Level Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late-stage development.
  • Assists the protocol lead in safety reporting activities for multiple clinical trials and may support collaboration with cross-functional colleagues within clinical development, clinical operations, case processing and medical safety review.
  • Key responsibilities include intake of reportable safety event information, review and management of individual case safety reports, generation of safety queries, and prioritization of daily work to ensure timely submission of events.

Matching Summary

The Scientist Level Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late-stage development.

Skills & Requirements

Must-have

  • Safety reporting in clinical trials
  • Individual case safety reports
  • GCP and ICH regulations
  • Cross-functional team collaboration
  • Advanced oral and written English skills

Nice-to-have

  • Independent analytical skills
  • Problem-solving capabilities
  • Sense of responsibility and accountability
  • Work under pressure

Key Requirements

  • M.D. with minimum 1 year clinical work experience
  • 2 years relevant pharmaceutical experience
  • Basic understanding of scientific and medical concepts
  • Basic understanding of drug development
  • Ability to work as part of a cross-functional team

Work Rights

Not specified

Tailored Resume

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