Responsibilities:
Perform end to end safety case processing activities by reviewing source documents coding relevant information and preparing case narratives to support accurate and timely pharmacovigilance reporting
Maintain consistent data quality in safety databases by performing detailed data entry checks query resolutions and reconciliation activities aligned with sponsor and regulatory expectations
Conduct routine case follow up activities by tracking missing information coordinating with internal teams and updating case records to improve completeness and clinical usefulness of safety data
Collaborate with cross functional colleagues in clinical operations medical information and quality units to ensure that safety information flows accurately and supports unified patient safety decisions
Utilize domain exposure in pharmacovigilance data management to interpret coding conventions and data structures that enhance consistency and usability of stored safety information
Contribute to continuous process improvement by suggesting practical changes to templates checklists and workflows that reduce rework and increase case throughput within the day shift schedule
Support preparation of safety metrics and summary reports by extracting key indicators from case data that help client teams monitor performance and identify emerging safety signals
Engage in regular training and knowledge refresh sessions to stay aligned with evolving pharmacovigilance regulations client procedures and best practices in pharma research and development
Adhere to hybrid work and data confidentiality protocols by following secure handling guidelines and using approved systems to protect sensitive health and product information
Communicate clearly with team members and supervisors about workload status data issues and timeline risks to enable proactive planning and reliable delivery for client projects
Contribute to knowledge sharing within the team by documenting case h