Director, Global Safety
O2 Technologies,Inc · Cambridge, MA · Yesterday
On-siteManagementContract
Key Responsibilities
- Signal Detection & Evaluation
- Agregate Safety Reporting (PBRER/PSUR/DSUR/INDAR)
- Benefit-Risk Assessment
- Safety Data Analysis
- Regulatory Submission Support (NDA/sNDA/MAA)
- Medical Review of Clinical Safety Data
- Cross-Functional Collaboration
- SOP & Documentation Development
- Training & Mentorship of Safety Staff
- Audit & Inspection Representation
- Project Leadership in Global Safety
Technical Skills
- Microsoft Excel
- Microsoft Word
- Microsoft PowerPoint
- Safety Database Management (ICSR)
- Data Retrieval & Validation Tools
Education & Experience
- MD or PharmD in Medicine, Pharmacy, Pharmacology, Clinical Research, Pharmaceutical Sciences
- Pharmaceutical/Biotechnology/Clinical Research/Drug Development/Post-Marketing Surveillance