Medical Safety Officer - Electrophysiology

Medical Safety Officer - Electrophysiology

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Johnson & Johnson is currently seeking a Medical Safety Officer (MSO) to join our team located in Irvine, CA or Plymouth, MN. The MSO provides medical safety stewardship for Medical Device (MD) products, evaluates safety signals, collaborates with cross‑functional teams, and supports risk management throughout the product lifecycle.

• Assess product risk‑benefit and offer medical input/review to:
  Risk Management Reports, Product Issue assessments, 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, including 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.
• 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 corrective actions.
• Ensure consistency in medical evaluations, Quality Review Board decisions and overall Safety evaluations of products.
• Deploy standard practices in coordination with MD CMO.
• Ensure appropriate metrics are used to assess adequacy of patient safety related processes.
• Contribute to and periodically review the definition of a product’s harms and hazards list and derivations of criteria for reportability.
• Act as subject‑matter‑expert in audit and other regulatory body interactions.
• Review and approve (from a medical safety perspective) appropriate reports and filings.
• Review responses to, for example, regulatory bodies, clinicians and patients when safety issues are involved.
• Coordinate with Regional Safety Officers to ensure timely coordination of information.

• Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent degree.
• Minimum of 3 years clinical or research experience.
• Relevant experience or specific training in Cardiovascular field.
• Ability to use common computer programs (Microsoft Office Outlook, Word, Excel, PowerPoint).
• Knowledge of basic statistical techniques and epidemiological principles.
• Knowledge of pre‑clinical or clinical research basic concepts.

• Preferred specialties:
  Electrophysiology, Interventional Cardiology, Cardiology, Interventional Radiology.
• Experience in risk evaluation and mitigation.
• Medical device and/or pharmaceutical industry experience in Health Care and/or device…