Manager, Pharmacovigilance Data Analysis 1
Tasks
- Collect prioritize and plan database and process improvements
- Coordinate regulatory safety data transmission
- Develop training documentation and work instructions
- Ensure safety database data consistency and integrity
- Lead integration and establishment of pharmacovigilance system
- Maintain pharmacovigilance application documentation
- Manage IT tickets for system compliance and improvements
- Manage change management for new processes and application integration
- Manage products and studies configuration updates in safety database
- Manage signal management
- Manage submission rules configuration updates in safety database
- Plan and prioritize scheduled IT tickets
- Provide operational support for global pharmacovigilance activities
- Supervise case listing extraction from safety database
- Supervise data extraction queries for periodic reports
- Supervise database queries for interval and cumulative cases
- Support drug safety applications administration
Perks/Benefits
- N/A
Skills/Tech-stack
Business Objects | Computer system | Computer system validation | Data Consistency | Data Integrity | E2B | Excel | GMP | MedDRA | Medical terminology | Oracle | Pharmacovigilance | PowerPoint | R2) | R3 | Regulatory Authorities | Regulatory Reporting | Signal management | System validation | Visio | Windows 7 | Word
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Regions
Countries
States
Cities
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