Safety Officer Business Intelligence
Core
Pharmacovigilance Business Intelligence & Aggregate Safety Reporting Analyst ensuring continuity of a key function in an international environment by gathering user needs and translating them into compliant GxP solutions.
Role type
Pharmacovigilance Business Intelligence Analyst
Builds
Regulatory and analytical reports (PSUR, DSUR, PADER, compliance, monitoring) using Business Objects
Domain
Life Sciences / Pharmacovigilance / Regulatory Reporting
Required skills
Pharmacovigilance processes, GxP requirements, Business Intelligence tools, Regulatory reporting (PSUR, DSUR, PADER), User support, IT interface management
Preferred skills
None stated
Technologies
Business Objects
Responsibilities
Configure and maintain regulatory and analytical reports; Interface between Pharmacovigilance business teams and IT teams; Provide user support and resolve incidents related to reports and data; Participate in documentation, validation, and compliance of systems; Support users during testing and acceptance of new features; Prioritize requests and tickets based on operational impact and regulatory criticality; Contribute to continuous improvement of reporting tools, processes, and practices
Seniority
Mid-level, hands-on IC
