This role predominantly performs Post-Market Surveillance activities including trend analyses, signal assessments and investigations. This is a new function and this role will be lead in developing procedures, processes and templates to support regulatory reporting requirements. This position will lead efforts in support of the business as it develops and implements product-specific safety surveillance strategies in proactive and systematic detection and evaluation of potential safety signals and emerging trends from post-marketing safety surveillance data. The individual will execute the Post-Market Surveillance processes with a primary focus on signal assessment and detailed investigations and reports of potential Safety Issues and Quality Trend Events.
Bachelors Degree (or equivalent experience) and/or 2-5 years of related experience or Masters Degree with no or little experience.
Advanced knowledge and use of Microsoft Excel for data analysis.
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