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Precision Medicine Group
Safety Specialist/Safety Lead
Remote · Japan · Mid level
About the role
Manage safety plans and serious adverse event case management for clinical trials. Provide safety expertise to team members, clients, and study sites.
What you’ll do
• Develop safety management plans. • Manage SAE case intake to regulatory reporting. • Interface with sponsors and vendors on safety processes. • Perform data entry, medical coding, and narrative writing. • Provide safety training and review SOPs.
What you’ll bring
• BA/BS degree. • Minimum 5 years safety experience. • Healthcare professional background. • Knowledge of MedDRA, WHODrug, FDA and ICH guidelines. • Experience with global safety databases and SAE processing.
Life at Precision Medicine Group
Equal Opportunity Employer with commitment to diversity and inclusion. Provides reasonable accommodations for disabilities.
About Precision Medicine Group
Precision Medicine Group is a Clinical Research Organization specializing in precision medicine, rare diseases, and oncology clinical trials.