Medical Reviewer Consultant

ClinChoice

Brazil, Brazil
On-site
Medical review of icsrs
Understanding of gvp modules
Experience across therapeutic areas
ClinChoice is seeking a Medical Reviewer Consultant in Brazil with 2-5 years of experience in medical review of Individual Case Safety Reports (ICSRs). The ideal candidate should possess an MBBS/MD, knowledge of regulatory guidelines, and be proficient in Japanese

Job Summary

  • Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative.
  • Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
  • Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.

Matching Summary

Match Score: 85

ClinChoice is seeking a Medical Reviewer Consultant in Brazil with 2-5 years of experience in medical review of Individual Case Safety Reports (ICSRs). The ideal candidate should possess an MBBS/MD, knowledge of regulatory guidelines, and be proficient in Japanese.

Skills & Requirements

Must-have

  • Medical review of ICSRs
  • Understanding of GVP modules
  • Experience across therapeutic areas
  • MedDRA coding
  • Safety database activities

Nice-to-have

  • Process improvement involvement
  • Training and mentoring skills
  • Adaptability to client conventions

Key Requirements

  • MBBS/MD with at least 2 years of experience
  • Thorough knowledge of ICH-GCP, GVP module, 21 CFR
  • Hands on experience with MS Office applications
  • Must be able to Write and speak Japanese

Work Rights

Not specified

Tailored Resume

Cover Letter