Director, Safety Data Analyst (M-Track)
POL - Mazowieckie Wojewodztwo - Warsaw (Trade Center), Poland
PLN 421K-673K (estimate) Executive-level Full Time
Tasks
- Develop business cases for investments
- Drive compliance governance and documentation
- Ensure pharmacovigilance case management
- Ensure process standardization and training control
- Implement process automation and continuous improvement
- Lead safety data management
- Lead system release implementation
- Maintain GxP ICH-GCP adherence
- Manage CAPA resolution
- Manage resources and budgets
- Oversee medical coding
- Partner on data integration and system enhancements
- Provide people leadership and performance management
- Support regulatory inspections and audits
Perks/Benefits
Skills/Tech-stack
Automation | CAPA management | Capacity Management | Data Management | Data Validation | Data integration | ECRF | Ethical Standards | Good Clinical Data Management Practice | Good Clinical Data Management Practice GCDMP | Good Clinical Practice | Good Clinical Practice (GCP) | GxP | ICH GCP | ICSR Management | Medical coding | Metadata Management | Pharmacovigilance | Process optimization | Reporting tools | Resource Planning | Risk Mitigation | S&OP | Safety data | Safety data management | Study Data Tabulation Model | Study Data Tabulation Model SDTM | System validation
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
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