Job Description :
Participates on project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality and compliance processes and process improvement initiatives Actively participate in the investment and strategy related to the technology decisions related to Quality Supports/promotes accuracy, internal consistency, uniformity, and compliance with regulatory commitments and expectations Provides support activities for regulatory inspections, internal audits and/or strategic quality initiatives Participates in special projects and senior management requests associated with safety compliance Maintains an understanding of ARGUS, Pfast, and case processing activities so as ensure the accuracy of safety data Compiles ICSR data quality metrics to ensure consistency within cases and correctness of the data relative to the AURG, SJAs and regulatory expectations Assists in the review of processes related to the collection and analysis of safety information Manages the completion of routine tasks by applying technical skills and specialized knowledge to coordinate initial findings, conduct root cause analyses, and corrective action planning with customers as necessary Collaborates with the therapeutic area leads regarding review of safety processes and/or documents that may affect projects, processes, product delivery Metrics reporting for all therapeutic area studies Support all the internal quality improvement initiatives
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