Senior Clinical Safety & Risk Strategist

Oracle; Hartford (CT); On-site; USD 74,000 - 148,000; Full time

Job summary

Oracle seeks a Patient Safety Strategist to provide independent clinical safety assessments for complaints involving regulated health software and SaMD. You will evaluate patient impact, document evidence-based conclusions, and support Clinical Impact Assessments and Health Hazard Evaluations while partnering with Quality, Regulatory Affairs, Product, Engineering, and Customer Support.

The role requires a clinical degree and licensure, six-plus years of direct healthcare or health-IT experience,

Qualifications

• Bachelor's degree or higher in a clinical discipline.
• Active clinical licensure or relevant certification.
• 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, CDS, medication management, orders and results, interoperability, identity, alerts, and health-IT functionality.
• Strong written clinical reasoning and ability to distinguish facts, inferences, uncertainty, and gaps.
• Ability to manage a high-volume case queue and escalate urgent or serious cases.
• Experience collaborating with nonclinical partners including Product Management, Engineering, Quality, Regulatory Affairs, and Customer Support.
• Strong judgment, organization, and communication skills.

Responsibilities

• Conduct timely, evidence-based clinical reviews of customer complaints involving regulated and non-regulated healthcare software (SaMD).
• Assess harm and determine whether information indicates a clinically significant safety concern or need for clinical evaluation.
• Document concise, defensible clinical rationale using approved frameworks.
• Lead or support Clinical Impact Assessments and provide input to Health Hazard Evaluations and vigilance activities.
• Identify missing clinical information and coordinate evidence requests with subject-matter experts.
• Participate in cross-functional complaint reviews while maintaining independent clinical-safety perspective.
• Identify safety signals and recurring complaint patterns and escalate trends.
• Support improvement of clinical-review templates, decision support, training, and AI-enabled tools.
• Meet global complaint-handling timelines and elevate risks affecting timely assessment.

Skills

Clinical safety assessment

Cross-functional collaboration

Clinical reasoning

Documentation

Education

Bachelor's degree or higher in Nursing, Medicine, Clinical or Medical Laboratory Science, Pharmacy, Allied Health, or related clinical discipline

Active clinical licensure or relevant certification

Tools

Cerner Millennium

EHR configuration

Job description

Oracle seeks a Patient Safety Strategist to provide independent clinical safety assessments for complaints involving regulated health software and SaMD. You will evaluate patient impact, document evidence-based conclusions, and support Clinical Impact Assessments and Health Hazard Evaluations while partnering with Quality, Regulatory Affairs, Product, Engineering, and Customer Support.

The role requires a clinical degree and licensure, six-plus years of direct healthcare or health-IT experience,