MDR Vigilance Specialist – Galway (Hybrid)

at  CREGG Recruitment

QUALIFICATIONS

• Minimum of Degree Level 8 in Mechanical/Biomedical Engineering/ Science or related discipline with 1-3 years of relevant experience desirable.
  For more information on this excellent Hybrid opportunity get in touch with
  Gary Keane
  Call: 061-363318
  Email: garykeane@cregg.ie

• 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.