Sneha Bambratkar
Operations Specialist @IQVIA
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WORK HISTORY
Operations Specialist @IQVIA
Thane, IN
Oncology Clinical Trial Experience (Metastatic Breast Cancer)Pharmacovigilance Experience (Rare Disease Units)PSUR / PBRER / Safety ReportingSafety Documentation & Regulatory UpdatesAstraZeneca (AZ) Products Knowledge
EDUCATION
PACIFIX RESEARCH PUNE
Post Graduate Diploma In Clinical Research and Pharmacovigiliance., Clinical Research
Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur
MSC , Biochemistry
Rashtrasant Tukadoji Maharaj Nagpur University
Bachelor's degree, Biotechnology
ABOUT SNEHA BAMBRATKAR
Accomplished Pharmacovigilance Professional with 5+ years of experience in global safety operations, specializing in case processing, regulatory compliance, and audit readiness. Proven expertise in managing end-to-end PV workflows, supporting FDA/EMA/GVP inspections, and driving process excellence. Recognized as a Subject Matter Expert (SME) with strong capabilities in mentoring teams, improving quality metrics, and ensuring 100% compliance with submission timelines.Core Competencies:End-to-End Case Processing (ICSR lifecycle)Global Regulations (FDA, EMA, GVP, ICH)Signal Detection & Risk ManagementArgus Safety Database (Advanced User)Audit & Inspection ManagementCAPA, RCA & Quality ComplianceVendor & Stakeholder ManagementProcess Improvement & AutomationTraining & Team Leadership
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