Safety Senior Manager - Medical Device
Tite: Senior Manager Medical Device Safety, Pharmacovigilance
Duration: 1 Year
Location Whippany, NJ
The incumbent provides counsel as PV medical device subject matter expert to ensure that an effective vigilance, post-marketing surveillance (PMS) and trending systems are implemented and maintained which conforms with global requirements/laws. The Senior Manager MDS works cross-functionally to generate solutions and implement process standards consistent with device industry best practices. The incumbent is a strong problem solver and communicator with a solid understanding of global regulations and standards.
The incumbent will be responsible for the production and accuracy of medical device analysis, interpretation of results and content contributions to PMS and Vigilance activities.
POSITION DUTIES & RESPONSIBILITIES:
- Provide content input to Project teams for designing, planning and conducting analyses of safety data for the assessment of medical device safety and performance.
- Provide content input to the post-marketing surveillance (PMS) program activities including, PMS system documentation, PMS planning and report management.
- Provide content input, develop and execute PMS trending methodologies, analysis, written contributions and trend report preparations.
- Responsible for monitoring, analyzing and applying trending methodologies to the vigilance data submitted to Health Authorities (e.g MDRs).
- Responsible for the production and accuracy of medical device analysis and interpretation of results.
- Independently review large data sets and prepare reports for submission the Health Authorities under strict timelines and resolved respective queries regarding product safety.
Skill & Competency Requirements:
- Strong scientific application of statistical methods used for evaluating complaint trends and establishing thresholds for routine trend reviews (e.g. human factor, malfunction, user interface and user safety)
- Background in medical device trending/signal detection and heavy statistical analysis experience.
- Able to develop and administer management information systems for track and trending.
- Strong analytical and technical skills that include data collection, analysis and required report generation
- Strong communication skills and ability to work both, independently and cross-functionally with Quality, Regulatory, Marketing and other applicable functions within the business
- Working understanding of medical device regulations and industry standards globally specifically 21 CFR 820, 803, ISO 13485, and euMDR 2017/745
- Bachelor's Degree in Engineering, Mathematics or Life-science Discipline with 4 years of professional experience in medical devices or similar sector
Sthree US is acting as an Employment Business in relation to this vacancy.