Manager of REMS Analytics

Job Summary

A company is looking for a Manager, REMS Analytics & Reporting.

Key Responsibilities

• Oversee the development of assigned sections of the REMS Assessment Report, ensuring accuracy and compliance
• Manage data collection, validation, and quality control for REMS Annual Timetable Assessments
• Conduct analytical assessments and coordinate with external vendors and stakeholders for data management

Required Qualifications

• Bachelor's or Master's degree in life sciences, public health, clinical research, health informatics, data science, or a related field
• Experience in data management and analysis, with REMS experience preferred
• Familiarity with Individual Case Safety Report (ICSR) processing and safety database applications
• Knowledge of MedDRA and WHO Drug Dictionary coding
• Experience in medical writing and preparation of regulatory documents