Manager, Pharmacovigilance Data Analysis
Tasks
- Coordinate database configuration updates for regulatory submissions
- Coordinate product and study database configuration updates
- Ensure safety database data consistency
- Interact with regulatory authorities for safety data transmission
- Lead PV system integration and establishment
- Lead change management for PV processes
- Maintain PV documentation
- Manage IT tickets for system compliance and improvements
- Manage signal management
- Obtain database case listings for specific situations
- Plan and prioritize scheduled IT tickets
- Supervise data extraction queries for PV documents
- Supervise periodic report case interval and cumulative case queries
- Support drug safety applications
Perks/Benefits
Skills/Tech-stack
Business Objects | Case management | Change Management | Data Consistency | Data Integrity | Data extraction | Database Administration | Documentation | GMP | GxP | MedDRA | Medical terminology | Microsoft Excel | Microsoft PowerPoint | Microsoft Visio | Microsoft Word | Oracle | Pharmacovigilance | Regulatory Reporting | Signal management | Technical writing | Validation | Windows
Education
Regions
Countries
States
Cities
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