Quality, Science, Pharmaceutical & Food
PE Global View all jobs
- Galway
- Permanent
- Full-time
- 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.
- Bachelor’s degree (Level 8 NFQ) in Engineering/ Science/ Legal/ Clinical or related discipline.
- 1-2 years relevant experience in a medical devices or related environment preferred.
- Dynamic team player who can work effectively and proactively on cross functional teams.
- Ability to think critically and make sound decisions.
- Strong attention to detail
- Knowledge of basic anatomy, physiology, and medical terminology
- Must be focused on patient safety and customer service, set high standards, instil operational excellence, drive accountability and model ethical behaviour.
- Good communicator and fluent in English, both in writing and speaking