Safety Science Specialist Full-time Job

• 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...