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Associate MDR/Vigilance Specialist
PE Global
·
4.0
Galway, County Galway
•
Hybrid work
Full-time
Apply now

Job details

Pay information not provided
Full-time
Hybrid work in Galway, County Galway

Full job description

The Role

PE Global are recruiting for an Associate MDR/Vigilance Specialist for our medical device client based in Galway. This is a 23-month contract role. Hybrid working options.

Job Responsibilities

  • Monitors the company's 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.

Education & Experience

  • Bachelor's degree (Level 8 NFQ) in Engineering/ Science/ Legal/ Clinical or related discipline.
  • 1-2 years relevant experience in a medical devices or related environment preferred.
  • Dynamic team player who can work effectively and proactively on cross functional teams.
  • Ability to think critically and make sound decisions.
  • Strong attention to detail
  • Knowledge of basic anatomy, physiology, and medical terminology
  • Must be focused on patient safety and customer service, set high standards, instil operational excellence, drive accountability and model ethical behaviour.
  • Good communicator and fluent in English, both in writing and speaking


Interested candidates should submit an updated CV.

Please click the link below to apply, alternatively send an up-to-date CV aisling.oleary@peglobal.net

****Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****

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