Senior Analyst, Office of Safety Operations

The Senior Analyst supports the Data Office Quality & Testing function by ensuring the quality, reliability, and integrity of safety data outputs through testing, quality oversight, and data governance activities. The role contributes to the broader Office of Safety Operations (OSOP) Systems, Data & Analytics mission of enabling patient safety, compliance, and operational excellence through trusted data and technology solutions.
The major responsibilities for this role include:
Understand data requirements defined by regulatory requirements, business functional processes
Communicate and train on data requirements to cross functional stakeholders
Testing of newly created or modified reports, queries, or dashboards
Manage evidence of testing activities and tracks defects to resolution
Maintenance of Data Governance Activities: Maintain the Report Inventory, Standards Library, and Data Dictionary as required
Perform Quality Checks (QC) of data in preparation for generation of large data extractions and reports. Manage evidence of Quality Check
Perform tests and oversee remediation to assure data quality
Provide input to defect tracking and root cause analyses. Provide reports for review and identification of potential trends.
Support surveillance configuration management activities by monitoring updates to safety monitoring plans, maintaining product and event configurations, and communicating configuration changes to stakeholders
Monitor data quality issues and oversee CAPA activities by supporting investigations, tracking corrective actions, and ensuring timely resolution of actions
Participate in quality improvement initiatives to identify potential process improvements or automated testing solutions.
Pharmaceutical industry experience; with experience in pharmacovigilance role preferred
Experience in performing tests, maintaining quality systems, or working in GxP environments preferred
Demonstrated attention to detail, good documentation practices, and effective communication skills required
Pharmacovigilance data experience preferred
Analytical, problem-solving, and decision-making abilities required
Capable of working efficiently in a team/matrix environment
Fluency in English and Romanian

Skills
Automation Testing, Pharmacovigilance, Documentation

Employment type
Full-time

Work arrangement
Hybrid