Job Description The Senior Manager, EU MDR/IVDR, Medical Governance and Analytics, will manage the Medical Safety Review Board (MSRB) process, including further developing and implementing the processes, methodologies and statistical tools required to collect, analyze and trend medical safety data to proactively identify potential adverse safety risks or trends. The individual will ensure compliance with applicable regulations and company policies/procedures. He/she ensures appropriate metrics/ Key Performance Indicators are defined, measured and analyzed for continuous improvement opportunity, product safety and performance. Additionally, the incumbent will develop and distribute Client analytical reports to management; lead cross-functional/business unit meetings; present safety data on a monthly basis to executive staff; communicate adverse safety risks or trends to management; develop, maintain and continually improve processes and procedures pertinent to the Client and Governance Operations group; and establish/maintain positive relationships with external and internal customers.
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position:
Partner with cross functional (i.e. Quality, Regulatory & Global Clinical Development) to develop and subsequently lead operational mechanisms to collect, review and analyze safety data and KPIs Tracks, trends and analyzes safety data using statistical tools and methodologies. Performs ad-hoc reports, communicates data to management, presents data to executive staff. This includes being able to work with complex data from multiple sources. Coordinate and lead Medical Safety Review Board (MSRB) meetings. This includes working crossfunctionlly with various business units to gather /analyze data, prepare presentations, coordinate meetings, manage presentation/lead meetings, manage meeting minutes and actions. Responsible for communicating adverse risks, trends, issues, or concerns in a timely fashion to the management team. Develops, maintains and continually improves processes and procedures pertinent to enterprise Client. Establishes and maintains positive relationships with external and internal customers. Supports the business units during internal external regulatory audits. Develops and implements reports, tools, queries and procedures as to support MA processes. Capable of providing routine or adhoc reports or requests in a thorough, accurate and timely manner. Support enterprise Client with the implementation of EU MDR/IVDR regulations. Work cross functionally/business unit (BU) to develop the Medical Safety Review Board (MSRB), which will be designed for safety signal detection review. This includes developing, gathering, managing and analyzing key safety KPIs, creating process flows and developing the MSRB content/material.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.