Our client a major multinational based here in Galway are looking for an MDR/Vigilance Specialist on an initial 23-month contract. This is a hybrid -2 days in the office, 3 working from home.
- 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.
- Established and productive individual contributor.
- Works independently with general supervision on larger, moderately complex projects/assignments.
- Problems and issues faced are general, and may require an understanding of a broader set of issues or other job areas but typically are not complex.
- Requires practical knowledge and demonstrated competence within job areas typically obtained through advanced education combined with experience.
- Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.
For more information on this role and a confidential discussion please contact Michelle Mc Inerney
091 706 717