Spclst, Clinical Data Mgmt
Core
Process adverse experience (AE) reports with high quality and compliance in the global safety system for investigational and/or marketed products.
Role type
Safety Data Specialist (Pharmacovigilance)
Builds
Global Pharmacovigilance Case Management operations
Domain
Healthcare / Pharmacovigilance
Deliverable
client delivery
Required skills
Case Processing, Clinical Data Management, Clinical Risk Management, Data Analysis, Data Processing, Pharmacovigilance, Standard Operating Procedure (SOP) adherence
Preferred skills
Management Reporting, Regulatory Compliance
Responsibilities
Perform triage, analysis, and interpretation of AE data following SOPs; serve as a Point of Contact for feedback on resources; assist with root cause analysis and implementation of action plans; meet Key Performance Indicators (KPIs).
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