Quick Overview
Seniority
Leader
Work mode
Hybrid
Location
Cambridge, MA, United States
Posted
Yesterday
Clinical ResearchMicrosoft ExcelMicrosoft PowerPointMicrosoft WordPharmacovigilancePharmacyRisk AssessmentRisk Management
Job Description
Key Responsibilities & Skills
- Pharmacovigilance & Risk Management
- Signal Detection & Evaluation
- Aggregate 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
- Microsoft Excel
- Microsoft Word
- Microsoft PowerPoint
- Safety Database Management (ICSR)
- Data Retrieval & Validation Tools
MD or PharmD in Medicine, Pharmacy, Pharmacology, Clinical Research, Pharmaceutical Sciences
Industry Experience- Pharmaceutical
- Biotechnology
- Clinical Research
- Drug Development
- Post-Marketing Surveillance
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