Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist
Participate in the assessment and set-up of a safety database to capture SAE data
Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of
QC of documents and safety reports
Preparation and/or review of project-specific safety reporting plans and medical coding plans
Preparation and/or review of safety training materials

🎯 Requirements

BA/BS degree
Minimum 5 years safety experience
Health care professional
Hands on experience with global safety database(s), SAE case processing including narrative
Working knowledge of MedDRA and WHODrug
Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations

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