Medical Safety Officer - Electrophysiology

Medical Safety Officer - Electrophysiology

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Product Safety

Product Safety Risk Management MD

Scientific/Technology

Irvine, California, United States;
New Brighton, Minnesota, United States;
Plymouth, Minnesota, United States;
Shoreview, Minnesota, United States

Johnson & Johnson is currently seeking a Medical Safety officer to join our team located in Irvine, CA or Plymouth, MN.

The Medical Safety Officer (MSO) role is to provide medical safety stewardship for Medical Device (MD) products. Although a medically independent voice is key, collaboration in assessing potential safety signals is expected. This individual is an active member of a diverse team, and a close partner with the quality leader and statistical colleagues, in assessing any potential safety signal for an MD product.

They will execute on the Medical Safety Organization’s strategy, by implementing programs and leading in the strategic priority areas as defined by the Chief Medical Officer.

The MSO will build clear and positive relationships between R&D, Quality, Regulatory, Clinical, Medical Affairs, Epidemiology and Safety sciences and Safety process and groups to allow for proactive and flexible risk management system. The MSO is knowledgeable in risk management and serves as a subject matter authority in the therapeutic area and patient risk management throughout the product lifecycle, from new product development, to launch and commercial life.

The MSO plays a pivotal role in evaluating customer/user risk and in assessing the actual or potential impact of product performance issues on patient safety. The reactive elements of the role (addressing Quality/performance issues) are balanced with the need for a proactive approach in continually assessing all available information/data sources and advising on any mitigating activities which should be taken to minimize potential risk to patients.

Further, the MSO must be a trusted partner in the innovation process, engaging with R&D and quality engineering to drive MD&D’s patient-centered innovation process.

The primary responsibility will be for Electrophysiology, Cardiac Imaging, Structural Heart, and Reprocessing.

• Assess product risk-benefit and offer medical input/review to:
  Risk Management Reports, Product Issue assessment/ Health Hazards Evaluations, Clinical Evaluation Reports, Product Safety Surveillance Plans (SSPs), including risk categorization of product/product families. Review and provide input on mitigations, labeling and internal and customer safety training materials directed to minimize patient risk and improve outcomes; adverse events, complaints and mass communications.
• Clinical interpretation of post-marketing safety data, aggregate complaint data, individual case safety reports, literature reports with possible safety data
• Input into design and interpretation of safety-related studies, and results of any SSP activities
• Represent Medical Safety in various product reviews during development
• Evaluation of medical impact of manufacturing and design issues
• Responsible for oversight and guidance as it relates to the performance and Medical Safety of products
• Monitor external sources/trends and identify and call out emerging issues. These include (but are not limited to): complaint & MDR/MDV trends, regulatory & market trends/intelligence, literature and scientific publications
• Advise on failure investigations and provide medical opinion when deciding on reportability
• Work with customers/users to gather additional medical information/ data when required to support investigations
• When required, review additional safety-related information to customers to prevent repeat adverse events and complaints
• Discuss with healthcare professionals (at their request) AE investigations as well as discussion of AEs that the customer experienced.
• Be the medical representative within the review process when making decisions on field actions and help evaluate the effectiveness of field safety…