Johnson & Johnson
Director Medical Safety Officer Neurovascular
Johnson & Johnson, Titusville, New Jersey, us, 08560
Johnson & Johnson is recruiting for a Director, Medical Safety Officer (Neurovascular) to be located in New Brunswick, NJ; Titusville, NJ; Raritan, NJ; Horsham, PA; California or Galway, Ireland. Other US locations may also be considered. Remote work options may be considered on a case-by-case basis and if approved by the Company.
The 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, 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 Cerenovus/ Neurovascular Solutions.
Principal Duties & Responsibilities:
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.
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.
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 corrective actions.
Ensure consistency in medical evaluations, Quality Review Board decisions and overall Safety evaluations of products.
Deploy standard practices in co-ordination 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.
QualificationsRequired:
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 a Cardiovascular or Interventional specialty.
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:
Preferred specialties: Neuro-interventional radiology, Interventional Radiology, Neurosurgery, Neurology, Interventional Cardiology, Vascular Surgery or Cardiology.
Experience in risk evaluation and mitigation.
Medical device and/or pharmaceutical industry experience in Health Care and/or device industry.
Clinical study/research experience.
Experience of working with senior leadership within a global healthcare company.
Advanced statistical knowledge (e.g. multivariate data analysis).
Knowledge of local and international Medical Device regulations.
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The 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, 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 Cerenovus/ Neurovascular Solutions.
Principal Duties & Responsibilities:
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.
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.
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 corrective actions.
Ensure consistency in medical evaluations, Quality Review Board decisions and overall Safety evaluations of products.
Deploy standard practices in co-ordination 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.
QualificationsRequired:
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 a Cardiovascular or Interventional specialty.
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:
Preferred specialties: Neuro-interventional radiology, Interventional Radiology, Neurosurgery, Neurology, Interventional Cardiology, Vascular Surgery or Cardiology.
Experience in risk evaluation and mitigation.
Medical device and/or pharmaceutical industry experience in Health Care and/or device industry.
Clinical study/research experience.
Experience of working with senior leadership within a global healthcare company.
Advanced statistical knowledge (e.g. multivariate data analysis).
Knowledge of local and international Medical Device regulations.
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