Rambabu R.

Principal Safety Specialist @Syneos Health

Maharashtra, IN

Working in Global Quality Improvement Plan (GQIP) team and serving as Subject Matter Expert (SME) and Global Trainer for the project.\\\\n\\\\nFacilitate the activities and drive GQIP initiatives to improve quality and to ensure quality of safety data and compliance with regulatory, company, and department requirements and directives.\\\\n\\\\nAlways support the review of controlled document, and revisions. Also, support for development of client-specific SOPs, WIs, and guidance documents for small projects.\\\\n\\\\nPerform testing of new changes prior to implementation in Production database e.g. WHO DD, MedDRA etc.\\\\n\\\\nTrack and communicate quality metrics to assess, evaluate, and facilitate team/individual achievement to the expected level of quality.(e.g. VOQR (external findings), internal corrections (ICF) and iPQR analysis).\\\\n\\\\nAlways identify, highlight, and communicate areas of risk in upcoming new processes within project.\\\\n\\\\nEscalate issues with project deliverables, performance metrics (including quality parameters), quality KPI and compliance to Line Manager as appropriate in a timely manner.\\\\n\\\\nPerform stakeholder review for new and/or revised SOPs and WIs and highlight challenges.\\\\n\\\\nDrive & participate in ICSR standard meetings to minimize regional differences for processing ICSRs.\\\\n\\\\nProvide training on new or updated SOPs, and WIs to team. So that, they remain up to date.\\\\n\\\\nTraining and mentoring of new hire resources of the Global Safety and Pharmacovigilance group involved in safety data processing and helping them to get on-boarded as early as possible.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n

University of Pune

Bachelor of Pharmacy (B.Pharm.)

Vel's University

M-Pharmacy