Description

You will support the configuration, maintenance, and improvement of pharmacovigilance systems, ensuring data quality and operational efficiency. Collaborate with cross-functional teams to troubleshoot issues, execute system updates, and support inspections.

Requirements

• Technical proficiency with pharmacovigilance systems
• Experience with system configuration, validation, and data extraction
• Familiarity with safety dashboards and analytics
• Knowledge of GxP and global regulatory requirements (FDA, EMA, PMDA)

Responsibilities

• Support system upgrades and maintenance by developing user/functional requirements and validation deliverables
• Execute routine configuration updates and maintain user roles, permissions, and access controls
• Troubleshoot system issues and coordinate resolution with internal teams and vendors
• Extract and format safety data for regulatory reporting and business partner inquiries
• Facilitate data-quality checks and investigate discrepancies