Manager Medical Device Safety, Pharmacovigilance

Skills

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.

Description

The Senior Manager Medical Device Safety (MDS) carries out global Pharmacovigilance (PV) business processes and analyses/trends safety data sets related to complaint handling, regulatory reporting and clinical development for Client's medical devices and combination products. The Senior Manager MDS is an expert who provides safety oversight and content contributions to design control, clinical evaluations, vigilance reporting to authorities, trending and post-marketing surveillance for CLIENT's Pharmaceutical and Consumer Health medical devices and combination products worldwide.

Responsibilities

• 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