MEDICAL SAFETY OFFICER, Vision

Product Safety Risk Management MD

The MSO role will provide medical safety stewardship for J&J Vision products. Although a medically independent voice is key, collaboration in assessing potential safety signals is expected. The MSO is an active member of diverse cross functional teams, and a close partner with the quality leader and statistical colleagues, in assessing any potential safety signal for J&J Vision products as assigned by the Senior Safety Officer.

The MSO 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 strong relationships between Medical Affairs, R&D, Quality, Regulatory, Clinical, Epidemiology through in-person collaboration, to allow for proactive and flexible risk management system. The MSO is knowledgeable in risk management and serves as a subject matter expert 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, Medical Affairs and quality engineering to drive J&J Vision's patient-centered innovation process.

The MSO will have primary responsibility for J&J Vision.

Duties and responsibilities include:

• In-person collaboration with Medical Affairs, R&D, Clinical and Regulatory in addition to in-person interfacing with senior leadership
• Chair the Safety Management Team (SMT)
• Responsible for conducting the First-in-Human triage meetings
• Oversight of the safety related aspects of the device including acceptance of the Benefit/Risk Profile throughout the product lifecycle including:
• Risk Management Reports
• Product Issue assessment/Health Risk Evaluations
• Review of and input into Clinical Evaluation Reports, specifically on benefit risk
• Product Safety Surveillance Plans (SSPs), including risk categorization of product/product families
• Represent Medical Safety in various product reviews during development. Provide medical input for specific project deliverables including:
• Design and Development plan or other documents identifying the members of the SMT
• Elements of Risk management
• Risk Management Plan
• Risk Management Report identifying the residual risk acceptance and Risk Benefit analysis
• Post Market Surveillance Plano Final Critical to Quality Cascades (relating to safety)
• Restricted Substances Evaluations (as applicable)
• Approval of Safety Content of Final Labeling and Instructions for Use (e.g. warnings, precautions, statements relating to risk mitigation, etc.)
• As chair of the SMT, oversight of a clinical study focusing on reviewing data generated for identification of any potential safety signals. Clinical study deliverables that are subject to SMT input and review include:
• The clinical study protocol(s)
• The Safety Management Plan
• Investigator Brochures
• Data generated as an output of the clinical study
• Safety reports that are to be submitted to regulatory bodies, Institutional Review Board(s), or Ethics Committee(s)o Final Clinical Study Report
• Clinical interpretation of:
• Post-marketing safety data
• Aggregate complaint data
• Individual case safety reports
• Literature reports with possible safety data
• Review and provide input on mitigations, labeling and internal and customer safety training materials directed to minimize patient risk and improve outcomes
• Evaluation of medical impact of manufacturing and design issues
• Provide medical safety expertise, oversight and guidance as it relates to the performance of products
• Monitor external sources/trends and identify and escalate emerging issues. These include (but are not limited to):
• Complaint & MDR/MDV trends
• Regulatory & market trends/intelligence
• Literature and scientific publications
• Review and provide input on Adverse Events, complaints and mass communications
• Advise on failure investigations and provide medical opinion when deciding on reportability
• Interface 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
• The MSO will 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 escalation process when making decisions on field actions and help evaluate the effectiveness of field safety corrective actions
• Ensure consistency in medical evaluations at Risk Management Board, and overall Safety evaluations of products
• Deploy best practice 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.
• Participate in Due-diligence activities for potential J&J Vision acquisitions.

Experience and education required:

• Doctor of Medicine (MD), Doctor of Osteopathy (DO), or non-US equivalent degree with relevant therapeutic specialty in an academic or hospital environment. Completion of residency in ophthalmology.
• Minimum of 3 years' clinical or research experience, or specific training related to the area of primary responsibility
• Basic knowledge of artificial intelligence (AI) tools, concepts and terminology.
• Ability to use common computer programs (Microsoft Office Outlook, Word, Excel, PowerPoint)
• Knowledge of basic statistical techniques
• Knowledge of basic epidemiological principles
• Knowledge of pre-clinical or clinical research basic concepts required
• The ability to influence decision-making with internal and external stakeholders is required.
• Must have excellent verbal and written communication skills.

Preferred:

• Fellowship in corneal or cataract surgery and board certification.
• Experience in risk evaluation and mitigation
• Medical device and/or pharmaceutical industry experience in Health Care and/or device industry
• Knowledge of local and international Medical Device regulations
• Advanced statistical knowledge (e.g. multivariate data analysis) is preferred.
• Experience of interfacing with senior leadership within a global healthcare company

Location and travel requirements:

• Location: Irvine, California
• Able to travel up to 25% based on needs of business

Required skills:

Preferred skills:

Clinical Operations, Compliance Management, Compliance Risk, Consulting, Design Mindset, Developing Others, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Quality Control (QC), Research Ethics, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Succession Planning, Surveillance

The anticipated base pay range for this position is:

$199,000.00 - $343,850.00

Additional description for pay transparency:

The anticipated base pay range for this position is: $199,000 - $342,700 The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance