· Implemented consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures
· Ensured compliance of operations with governing regulatory requirements
· Created, maintained, and assumed accountability for a culture of high customer services
· Executed drug safety data management processes – a combination of case entry, medical coding, narrative writing, peer review, case follow-up, report preparation and submission to regulatory authorities – with accountability for quality and timeliness of deliverables and responsibility for process improvements
· Performed any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources including literature search
· Assumed responsibility for quality of data processed
As Senior Safety Science Specialist in Fortrea Inc., I work as a strong team player as safety science specialists to ensure compliance with standard operating procedures (SOP) and good clinical practice (GCP) for pharmacovigilance and regulatory projects. I have over 4 years of experience in the life sciences industry, working with global clients and partners to deliver high-quality and timely solutions. I have a master of pharmacy degree from JSS University, Mysuru and I have developed skills in regulatory affairs, quality management, and risk assessment. I am passionate about improving patient safety and health outcomes through innovative and collaborative approaches. My goal is to leverage my expertise and experience to contribute to the mission and vision of Fortrea Inc.