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MDR/Vigilance Specialist @ Medtronic

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 MDR/Vigilance Specialist

Job Description

A Day in the Life Our Global Diabetes Capability Center in Pune is expanding to serve more people living with diabetes globally. Our state-of-the-art facility is dedicated to transforming diabetes management through innovative solutions and technologies that reduce the burden of living with diabetes. We re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation, join our new Minimed India Hub as a MDR/Vigilance Specialist. This role offers a dynamic opportunity to join Medtronics Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. While you will start your employment with Medtronic, upon establishment of SpinCo or the transition of the Diabetes business to another company, your employment transfer to either SpinCo or the other company, at Medtronics discretion and subject to any applicable information and consultation requirements in your jurisdiction.
Job Responsibilities include the following and other duties be assigned:
  • Monitors the companys drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
  • Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
  • Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
  • Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Job Classification

Industry: Medical Services / Hospital
Functional Area / Department: BFSI, Investments & Trading
Role Category: Life Insurance
Role: Actuarial Analyst
Employement Type: Full time

Contact Details:

Company: Medtronic
Location(s): Hyderabad

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Keyskills:   Medical devices Regulatory reporting Protocol development Consulting Manager Technology Transition Database Healthcare Management Room

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Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of  what technology, therapies and services can do to help alleviate pain, restore health and extend life.We challenge ourselves and each other to make tomorrow better than yesterday. It is what mak...