Senior Associate Safety Data Analyst

Overview

Support changes and configuration for a global pharmacovigilance safety system and associated data outputs.

What you'll do

• Generate safety system outputs for periodic safety reports and signal detection audits.
• Ensure automated and scheduled safety data outputs are delivered.
• Perform quality checks and peer review for data outputs and routine system configurations.
• Collect business requirements for routine safety data outputs.
• Implement routine safety system configuration, including reporting rule updates and product/study configuration.
• Support study startup, including RAVE-Argus mapping and UAT activities.
• Contribute to training, quick reference guides, and technical solutions for safety database and tools.

What you'll need

• Knowledge of safety systems including LifeSphere MultiVigilance platform/Argus and query/reporting tools such as Cognos and Tableau.
• Understanding of data warehouse concepts and data mining techniques.
• Knowledge of software development lifecycle and validation methodology.
• Understanding of global regulatory requirements for pharmacovigilance and safety reporting.
• Familiarity with clinical trial and pharmacovigilance processes.
• Ability to interpret aggregate safety data using statistical analysis.
• Experience supporting inspections or internal audits.