Safety Data Lead I
Hybrid
Core
Analysis and interpretation of adverse event (AE) reports for investigational and marketed products in compliance with regulatory requirements.
Role type
Safety Data Lead (Pharmacovigilance)
Builds
Adverse event case management and regulatory reporting
Domain
Life Sciences / Pharmacovigilance
Required skills
Data Processing, Data Quality Assurance, Data Review, Data Validation, Pharmacovigilance, English Language, Japanese Language
Preferred skills
Data Management, Japanese to English Translation, Quality Management
Responsibilities
Performing analysis, interpretation, and data entry of adverse event reports from various sources; Collaborating with internal and external stakeholders to resolve issues and ensure compliance; Supporting simplification and optimization of case management activities.