• Medical Events Specialist I Jobs in United States Of America

  • Abbott India Ltd
  • United States Of America, Usa
  • Save Job
  • 2 - 5 Years
  • Posted : above 1 month

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines Our 103,000 colleagues serve people in more than 160 countries

JOB DESCRIPTION Responsible for timely review, documentation and filing of Medical Device Reports, including international vigilance reports for the divisions products Accountable for meeting the compliance requirements for Medical Device Reporting regulations including (803) This includes but is not limited to the efficient and timely review, documentation and filing of potentially reportable events

Responsibilities
Review medical complaints and potentially reportable events for the purpose of researching and gathering additional information needed to determine MDR and/or Vigilance reportability

Interact with cross functional teams (eg Customer Service, Complaint Evaluations Group and Complaint Investigations Group) to gather appropriate information to determine whether a complaint requires an MDR and/or Vigilance report and/or submit a MDR/Vigilance follow up report

Document filing decision rationale in the Complaint Handling System

Filing of all medical events and reportable malfunctions within the required timeframe

Provide feedback and recommends solutions within the Quality team to promote accurate documentation of the complaint case

Assist in maintaining the Malfunction Reportability Assessment Matrix (MRAM), including updates to the Reportable Confirmed Malfunction List (RCML)

Perform verification of MDRs/Vigilance reports, including support of data compiled for metrics, risk evaluations and various other activities

Assure compliance to the divisions Medical Event and Quality System procedures

Interface with management and other functional areas to ensure that Potential Reportable Events (PREs) are obtained in a timely and consistent basis

The documentation of the work of the Medical Event Analyst is scrutinized by the Regulatory Agencies on a regular basis and compliance is measured by the accuracy and completeness of these documents Failure to properly evaluate or report complaints could result in observations from regulatory agencies

Qualifications
Associate Degree or an equivalent combination of education and work experience Minimum 2 years working in a quality related role, or equivalent time in clinical laboratory, medical clinic, or nursing experience

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : IT Software : Software Products & Services
Role : Quality Assurance/Testing
Salary : As per Industry Standards
Deadline : 19th Feb 2020

Key Skills:

Company Profile:

Company
Abbott India Ltdarfix

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