Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures
Ensure compliance of operations with governing regulatory requirements
Create, maintain and assume accountability for a culture of high customer service Operational
Execute drug safety data management processes \xe2\x80\x93 a combination of call intake, call dialogue documentation, peer review, case follow-up, report preparation and submission to regulatory authorities
Guide Junior Safety Data Analyst (Voice) in managing voice calls (as required)
Perform any other support activities as assigned \xe2\x80\x93 tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources including literature search
Assume responsibility for quality of data processed
Voice call management
Pharmacovigilance
Clinical Research
Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH-GCP guidelines
Technical proficiency with Microsoft Office suite applications
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