Pravin Aute
Principal Safety & Pv Specialist @Syneos Health
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WORK HISTORY
Principal Safety & Pv Specialist @Syneos Health
Pune, IN
Works independently to oversee day to day Safety and Pharmacovigilance (SPVG) activities on assigned projects/programs.\\\\n• Exercises independent judgement to troubleshoot and resolve project issues and to identify areas for improvement.\\\\n• Develops innovative solutions to meet unique, client-specific requirements.\\\\n• Supports management/lead in reviewing and presenting prepared information at project or departmental review meetings.\\\\n• Develops training materials, conducts training presentations and on-the-job-training for appropriate departmental teams.\\\\n• Participates in and/or leads departmental initiatives to increase efficiencies and optimize processes.\\\\n• Serves as a subject matter expert in SPVG.\\\\n• Presents at client/investigator meetings.\\\\n• Assists in the tracking and measuring of program/project and team progress through collection of cycle time metrics and other key performance indicators (KPIs). Proposes solutions to issues that may arise and strategies to improve metrics/cycle times.\\\\n• Leads teams of subject matter experts in the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes.\\\\n• Participate in audits/inspections as the SPVG SME.\\\\n• Maintains understanding and compliance with SOPs, WIs, global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, study/program plans and the drug development process.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
EDUCATION
University of Pune
Bachelor of Pharmacy, Pharmaceutical Sciences, First Class
University of Pune
Master of Pharmacy, Quality Assurance Techniques, First Class with Distinction
Pune Zilha Shikshan Mandals Annasaheb Magar Mahavidyalaya Arts, Science & Commerce, Hadapsar, Pune 28
11-12th, Science, First Class
ABOUT PRAVIN AUTE
Experienced drug safety specialist with a demonstrated history of working in the pharmaceuticals, ITeS and clinical research industry. Skilled in Aggregate reporting, Signal detection, Medical literature review, European Medicines Agency Medical Literature Monitoring (EMA MLM), ICSR, eTMF, Retrospective Quality Review and Vendor Quality Management activities. 21 CFR Part-11 validation, change control management, testing and implementation of business applications. Experience in writing and execution of test scripts, review of validation protocols IQ/OQ/PQ documentation. Strong professional with a Master of Pharmacy focused in Quality Assurance Techniques from University of Pune.
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