The Safety Data Lead I is responsible for the analysis and interpretation of adverse experience (AE) reports of varying complexity, in compliance with regulatory requirements and internal processes. Working under the supervision of a GPVCM Manager, the Safety Data Lead executes AE case management activities for both investigational and marketed products in accordance with specific therapeutic area standards. Collaboration with internal and external stakeholders is essential to maintain high quality and timely execution of the processes.
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Among other tasks, the Safety Data Lead is responsible for:62
- Performing analysis, interpretation, and data entry of adverse event reports from a wide range of sources and therapeutic areas, demonstrating increasing proficiency in clinical knowledge, GPVCM processes and regulatory guidelines.
- Providing support or leading operational activities appropriate to level of experience and expertise.
- Collaborating with internal and external stakeholders to resolve issues of varying complexity to guarantee process standardization and adherence and ensure compliance with reporting requirements.
- Supporting simplification and optimization of case management activities to enhance overall effectiveness.
#Global Data Management Standard