MDR Vigilance Specialist
We are looking to speak with experienced MDR Vigilance Specialist about this great new job opportunity in Galway with one of our leading clients? This company stands out for their culture, exceptional career development pathways and unrivalled rewards and recognition packages. This exciting new job opportunity in MDR Vigilance Specialist is located Galway. Galway, voted “Europe most Friendliest City 2020”! Apply to us to find out more about this great job opportunity in Galway and we can talk though if it’s the right job for you.
- 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.
- Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
- May act as a mentor to colleagues or may direct the work of other lower level professionals.
- The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University)
- Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
- Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
- Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments
- Sets objectives for own job area to meet the objectives of projects and assignments.
- Contributes to the completion of project milestones .
- May have some involvement in cross functional assignments.
For further information on this role in Galway please contact Aisling Kidney on or
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