We're looking for a Medical Reviewer to join our team.
Job Overview
The ideal candidate will possess a medical background and experience in reviewing ICSRs, with a strong understanding of GVP modules, ICH-GCP, and other regulatory requirements. The role requires the ability to work independently, prioritize tasks effectively, and maintain a high level of accuracy.
Key Responsibilities:
* Review ICSRs for completeness and accuracy, ensuring compliance with regulatory guidelines.
* Perform non-serious & serious ICSR reviews with emphasis on quality & compliance.
* Develop and maintain expertise in product portfolios and safety profiles.
* Collaborate with cross-functional teams to identify and address case issues.
* Maintain up-to-date knowledge of international safety regulations and guidelines.
Requirements:
* MBBS/MD degree with at least 2 years of experience as a Medical Reviewer for ICSRs.
* Strong knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines, and other regulatory requirements.
* Excellent training and mentoring skills in GVP concepts and medical aspects.
* Proficiency in MS Office applications and ability to write and speak Japanese.