PV Analytics & Reports Lead
Tasks
- Collect regulatory requirements and develop reports
- Develop and maintain regulatory reports
- Document user requirements in backlog
- Facilitate support and training sessions
- Lead or participate in internal audits and external inspections
- Maintain GxP validated PV reporting and analytics systems
- Maintain system access and perform access management reviews
- Maintain training materials for releases
- Manage hosting vendor
- Manage system releases and service management
- Manage user requests with digital teams and vendor
- Manage user requirements and configuration specifications
- Provide audit support with ad hoc reports
- Provide system and administration support
- Resolve and escalate incidents
- Support oversight of vendor staff and monitor KPIs
Perks/Benefits
- N/A
Skills/Tech-stack
Adverse Event | Adverse event reporting | Data Migration | Event Reporting | Excel | GxP | ICH GCP | Mitigation Strategies | Operations support | PLSQL | Periodic Safety Update Reports | Pharmacovigilance | Pharmacovigilance Regulations | PowerPoint | Process Improvement | Regulatory Reporting | Risk Evaluation | Risk Management | Risk evaluation and mitigation strategies | SQL | Safety Update Reports | Stakeholder management | System validation | Systems Operations | Systems Operations Support | UAT | User Requirements | Word
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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