Senior Drug Safety Specialist

IQVIA

Brazil
Fully remote
Process icsrs from clinical trials
Medical coding and narrative writing
Global pharmacovigilance regulations knowledge
The role involves processing Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources to ensure timely submissions

Job Summary

  • The role involves processing Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources to ensure timely submissions.
  • Candidates must possess a strong understanding of global pharmacovigilance regulations including ICH, GVP, FDA, and EMA standards.
  • This position requires advanced English proficiency and offers the opportunity to work remotely based in Brazil.

Matching Summary

The role involves processing Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources to ensure timely submissions.

Skills & Requirements

Must-have

  • Process ICSRs from clinical trials
  • Medical coding and narrative writing
  • Global pharmacovigilance regulations knowledge
  • Safety database experience
  • Advanced English language skills

Nice-to-have

  • Clinical knowledge of therapeutic areas
  • Previous pharmaceutical industry experience
  • Advanced Spanish language skills
  • Continuous improvement initiative support

Key Requirements

  • Bachelor's degree in Life Sciences or related field
  • Minimum 1 year drug safety experience
  • Advanced English mandatory
  • Experience with safety databases

Work Rights

Not specified

Tailored Resume

Cover Letter