Vyshnavi Chillara
Senior Mdr Vigilance Specialist @美敦力
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WORK HISTORY
Senior Mdr Vigilance Specialist @美敦力
Telangana, IN
Evaluates incoming complaint information and maintains the record in the electronic database.•Performs follow up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data on all complaints.•Determines Reportability of complaints & submits Regulatory Reports to FDA.•Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.•Writes investigation summaries based on technical product analysis information provided; •Ensures record documentation is maintained in a constant state of audit readiness per internal policies.•Liaison with groups who perform additional investigation and who prepare written record of investigation.•Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.•Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations.•Reviews and interprets risk management documentation as it applies to the complaint event. •Interact with multiple departments within Medtronic, such as Technical Services, Failure Investigation, R&D, Manufacturing and Engineering.•Liaison with groups external to Medtronic - RTG, such as customers, vendors, health care professional.
EDUCATION
Siddartha High School
Maths,Science
Jawaharlal Nehru Technological University
B.Tech
Narayana Junior College
Intermediate
ABOUT VYSHNAVI CHILLARA
As a Senior MDR Vigilance Specialist at Medtronic, more than three years of experience…
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