Our client a major multinational here in Galway are looking to hire an Associate MDR & Vigilance Specialist on an initial 23 month contract.
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.
Requirements:
- Qualified person to Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline.
- 2 years relevant experience
- Dynamic team player, attention to detail, goal-orientated, good communicator and problem solving skill-sets.
- Medical device experience desirable
- 100% desk based
For more information or a confidential discussion about this role please contact Michelle Mc Inerney
michelle.mcinerney@collinsmcnicholas.ie
091 706 717