Science, Pharmaceutical & Food
MDR / Vigilance Specialist – Galway
PE Global are recruiting for an MDR/Vigilance Specialist for our medical device client based in Galway. This is a 23-month contract role. Hybrid role (2 days onsite, 3 days remote).
- 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.
- Review and analyse 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.
- 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.
- Ensure highest quality of product event data entry for accuracy of reporting to regulatory agencies.
- Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
- Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.
Education & Experience
- Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline or candidates with a legal or clinical qualification.
- Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
- Experience in a pharmaceutical, medical device, manufacturing background
- Good attention to detail, organisational and communication skills
Interested candidates should submit an updated CV.
Please click the link below to apply, call Ciara on 021- 4297900 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****