Scientist - Medical Review Physician
ClinChoiceCore Responsibilities
Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative. Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling and review narrative. Provide medical guidance and expert opinion on cases to data entry associates and quality reviewers.
Requirements
MBBS/MD with 2-4 years of experience as Medical Reviewer for ICSRs. Thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
Additional Information
Experience Level
Mid-Level
Employment Type
permanent
Work Mode
On-site