Senior Medical Safety Analyst
2 weeks ago
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Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac, PediaSure, Pedialyte, Ensure, Glucerna and ZonePerfect – to help get the nutrients they need to live their healthiest life.
PURPOSE OF THE JOB
As an individual contributor, with guidance from manager/team, functions to support Medical Safety & Surveillance (MSS) by reviewing, assessing, and summarizing medical device complaint information for complex investigations and risk assessments. Critically assess aggregate safety data from medical devices and communicates findings to internal stakeholders. Independently creates and delivers device medical safety training to a Global audience. Drafts documentation, including data reviews, clinical evaluations, literature reviews and standard operating procedures.
MAJOR RESPONSIBILITIES
- Create and present medical safety related analyses, reports, and/or assessments orally and/or in writing within/ outside the Medical Safety and Surveillance department.
- Gather, critically analyze, and present findings from Medical Safety and Surveillance complaint data on a periodic basis, including tracking and trending activities.
- Ensure adherence to departmental standard operating procedures (SOPs), and draft new SOPs as needed.
- Develop Medical Safety and Surveillance training materials and provide training to a broad international audience.
- Assist in preparing, completing literature or website searches and data analysis for regulatory documentation supporting medical device registration.
- Conduct periodic literature searches, summarize findings and present information to a cross-functional team.
- Act as a backup to colleagues on day-to-day medical device complaints processing and conduct medical follow-up calls to customers as needed to obtain adverse event and/or complaint details.
- Determine complaint reportability to the competent authority; drive on-time vigilance reporting within regulatory time-frames.
- Other duties/projects/support as assigned.
EDUCATION & COMPETENCIES
- Bachelor of Science, a Health science related background is a plus, such as dietitian, pharmacist, nurse etc.
- 2-3 years Medical Device experience in activities such as aggregate data review, Risk Assessment, DFMEA review, and patient safety.
- Data analytics / strong excel, PowerBI and/or data visualization skills.
- Medical knowledge to apply critical thinking and data analysis to Medical Safety data and/or Medical Device risk assessments.
- Basic understanding of Global Medical Device regulations (primarily EUMDR, MedDEV), clinical research, and international guidelines/ standards related to medical devices (ISO, GSPR, MDGC etc.).
- Willingness to learn other applicable Medical Device regulations, standards and guidelines.
- Drive to adhere to standard operating procedures (SOPs).
- Strong ability/experience in presenting medical and scientific training/data orally and in writing.
- Computer proficient (Windows, Word, Excel).
- Enjoys working in a collaborative environment and with a multidisciplinary, Global team.
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