MDR Vigilance Specialist – Galway
CREGG Recruitment
- Galway
- Permanent
- Full-time
Fantastic Opportunity to join a well known Med Device company in the Galway area as an MDR Vigilance Specialist.Key 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.
- Minimum of Degree Level 8 in Mechanical/Biomedical Engineering/ Science or related discipline with a minimum of 1-3 years of relevant experience.