Organize, manage, and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity.
?Carry out all case management activities as appropriate.
?Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
?Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios
?Ensure complete and timely forwarding of ICSR to Core
?Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed.
?Consistently apply regulatory requirements and Client policies
?Analyze and monitor activities, define and implement corrective actions, where applicable.
?Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database.
?Provide oversight and team mentoring on case handling aspects, data extraction, and analyses.
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