Quality , Science, Pharmaceutical & Food
Associate MDR/ Vigilance Specialist- Galway
- Galway, County Galway, Ireland
PE Global are recruiting for an Associate MDR/Vigilance Specialist for our medical device client based in Galway. This is a 23-month contract role. Hybrid working options.
- 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.
- 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.
Education & Experience
- 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
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up-to-date CV firstname.lastname@example.org
****Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****