Senior Analyst, Office of Safety Operations

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at  . Follow @abbvie on  LinkedIn,   Facebook ,  Instagram ,  X and  YouTube.

Job Description

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.

Qualifications

• 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

Additional Information

This is a hybrid role with office location Bucharest. We look forward to receive your application, closing date for applications is the 6th of November. Please note we are not working with recruitment agent for this position so please direct all applications to AbbVie.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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