Interface with sponsors, vendors, and internal teams to design safety tools and reports.
Assess and set up a safety database to capture SAE data.
Perform intake, triage, data entry, medical coding, and ICSR narratives.
QC of documents and safety reports.
Prepare/review project-specific safety reporting and medical coding plans.
Prepare/review safety training materials and provide training.

🎯 Requirements

BA/BS degree
Minimum 2 years safety experience
Healthcare professional
Hands-on with global safety databases and SAE case processing
MedDRA and WHODrug knowledge
FDA safety regulations and ICH guidelines

🎁 Benefits

Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance and disability benefits
Parental leave and paid time off for sick leave and vacation

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