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Job Description:

Johnson and Johnson MedTech Vision is recruiting for a Senior Safety Officer located in Jacksonville FL.

The Senior Safety Officer (SSO) leads the medical safety function for MedTech Vision and oversees Medical Safety Officer activities for Vision Care. The SSO ensures proactive safety data assessment rigorous risk-benefit evaluations and clear communication of risks to Senior Management Health Authorities Prescribers and Patients. As a member of the Chief Safety Officers leadership team the SSO chairs the Safety Management Team with an independent medical perspective aligns safety processes with J&J standards and partners across Medical Affairs Quality and MD leadership to optimize safety across the Vision portfolio and potential acquisitions.

Key Responsibilities:

• Own end-to-end risk-benefit assessments for Vision Care in partnership with the MSO for Surgical Vision delivering robust Risk Management Reports Health Risk Evaluations and Clinical Evaluation Reports to inform benefit-risk conclusions.
• Lead Product Safety Surveillance Plans (SSPs) and risk categorization for product families ensuring timely input into safety responses to Adverse Events (AEs) complaints and mass communications.
• Provide expert interpretation of post-marketing safety data aggregate complaint data and literature reports; supervise First in Human Committee triage and safety signal evaluations.
• Chair Safety Management Teams serve on the QRB as the Medical Safety representative and drive consistency in medical evaluations and QRB decisions across the Vision portfolio.
• Ensure Medical Safety training and competency development for MSOs and secure necessary resources by partnering with responsible functions to close gaps quickly.
• Align safety processes with enterprise Safety Principles MD CSO/CMO guidance and Quality Risk Management; support due-diligence activities for potential MedTech acquisitions.
• Track and improve safety performance through defined metrics (e.g. timeliness of risk assessments SSP milestone completion training completion rates and effectiveness of safety communications).

Qualifications

Education:

• Doctor of Medicine (MD) or equivalent such as MBChB with specialization in Ophthalmic Surgery.
• Minimum of 5 years clinical experience in Ophthalmic Surgery

Experience and Skills:

Required:

• 10 years or more clinical pharmaceutical and/or medical device experience

Preferred:

• Experience in risk evaluation and mitigation
• Experience in matrixed organizations
• Medical device and/or pharmaceutical industry experience
• Clinical study/research experience
• Experience of interfacing with senior leadership within a global healthcare company

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