Manager, REMS Analytics & Reporting
Tasks
- Align cross functional REMS analytics reporting resolve timeline quality issues
- Conduct REMS metric development trend analysis performance monitoring
- Coordinate external vendors and REMS stakeholders for data exchanges
- Develop REMS assessment report sections
- Ensure SOP compliance complete required training
- Manage REMS data collection validation quality control
- Mentor RSO team members
- Prepare for REMS audits and inspections identify process improvements
- Respond to FDA information requests with data analysis
Perks/Benefits
- N/A
Skills/Tech-stack
Argus | ArisG | Data Analysis | Data Management | Data Validation | ICSR processing | Individual case safety report | MedDRA | Medical writing | Metric development | Microsoft Excel | Microsoft Outlook | Microsoft PowerPoint | Microsoft Word | Performance Monitoring | Quality Control | REMS | Regulatory writing | Safety database | Trend analysis | WHO Drug | WHO Drug Dictionary
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Roles
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