Senior Clinical Safety Strategist: SaMD & EHR Risk Expert

Oracle; Frankfort (KY); Presencial; USD 74.000 - 148.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Dental and vision insurance

Paid time off and holidays

401(k) with company match

Disability and life insurance

Descripción de la vacante

Oracle seeks a Patient Safety Strategist to perform independent clinical safety assessments of complaints related to regulated health software and medical-device functionality. You will evaluate patient impact, document evidence-based conclusions, and collaborate with Product, Engineering, Quality, Regulatory Affairs, and Customer Support.

The role emphasizes independent clinical judgment, timely reviews, and clear documentation to support regulatory decisions and product improvements.

Formación

• Bachelor’s degree or higher in Nursing, Medicine, Clinical or Medical Laboratory Science, Pharmacy, Allied Health, or a related clinical discipline.
• Current, active clinical licensure or relevant professional certification in an applicable clinical discipline.
• Six or more years of direct clinical practice, clinical informatics, patient safety, health technology, or regulated healthcare-product experience.
• Ability to assess patient-safety implications of EHR workflows, clinical decision support, medication management, orders and results, interoperability, identity, alerts, and other health-IT functionality.
• Strong written clinical reasoning skills, including the ability to distinguish documented facts, reasonable clinical inferences, uncertainty, and information gaps.
• Ability to manage a high-volume case queue while recognizing and escalating urgent or potentially serious cases.
• Experience collaborating with nonclinical partners, including Product Management, Engineering, Quality, Regulatory Affairs, and Customer Support.
• Strong judgment, organization, and communication skills.

Responsabilidades

• Conduct timely, evidence‑based clinical reviews of customer complaints involving regulated and non‑regulated healthcare software, including Software as a Medical Device (SaMD).
• Assess reported or potential patient and end‑user harm and determine whether available information indicates a clinically significant safety concern, potential product‑related deficiency, or need for further clinical evaluation.
• Document concise, defensible clinical rationale using approved complaint‑handling and clinical‑review frameworks.
• Lead or support Clinical Impact Assessments and provide clinical input to Health Hazard Evaluations, vigilance activities, benefit‑risk assessments, field‑action assessments, and other assigned post‑market safety activities.
• Identify missing clinical or functional information and coordinate focused evidence requests with Product, Engineering, Quality, and other subject‑matter experts.
• Participate in cross‑functional complaint reviews while maintaining an independent clinical‑safety perspective.
• Identify potential safety signals and recurring complaint patterns, escalating significant trends through established governance channels.
• Support continuous improvement of clinical‑review templates, decision support, training, and approved AI‑enabled tools.
• Meet global complaint‑handling timelines and elevate risks that may affect timely assessment or reporting.

Conocimientos

Clinical safety assessment

Evidence-based reasoning

Stakeholder collaboration

Project management

EHR workflow assessment

Written communication

Educación

Bachelor’s degree or higher in Nursing or Medicine or related clinical discipline

Active clinical licensure or professional certification

6+ years direct clinical practice/healthcare experience

Herramientas

Cerner Millennium

Oracle Health

Descripción del empleo

Oracle seeks a Patient Safety Strategist to perform independent clinical safety assessments of complaints related to regulated health software and medical-device functionality. You will evaluate patient impact, document evidence-based conclusions, and collaborate with Product, Engineering, Quality, Regulatory Affairs, and Customer Support.

The role emphasizes independent clinical judgment, timely reviews, and clear documentation to support regulatory decisions and product improvements.