Safety Data Lead I
Core
Analysis, interpretation, and data entry of adverse experience (AE) reports for investigational and marketed products in compliance with regulatory requirements.
Role type
Safety Data Lead I
Builds
Adverse event case management processes and data quality for global pharmacovigilance.
Domain
Pharmaceutical, Pharmacovigilance, Drug Safety
Deliverable
production ML models
Required skills
Pharmacovigilance, Adverse Event Data Entry, Regulatory Compliance, Clinical Knowledge, Data Analysis, English (fluent), Japanese (fluent)
Preferred skills
Adverse Drug Reaction (ADR) Monitoring, ADR Reporting, Drug Safety Surveillance
Technologies
Global Pharmacovigilance Case Management (GPVCM) systems
Responsibilities
Perform AE case management, interpret adverse event reports, ensure regulatory adherence, collaborate with stakeholders to resolve issues, support process optimization.
Seniority
Entry to Mid-level, hands-on IC
