Senior Patient Safety 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

Job Description

The Patient Safety Strategist provides independent clinical safety assessments for complaints involving regulated health software, medical-device functionality, and clinically significant customer-reported events. The role evaluates potential patient and end-user impact, documents evidence-based clinical assessments, supports Clinical Impact Assessments, Health Hazard Evaluations, and collaborates with Quality, Regulatory Affairs, Product, Engineering, and Customer Support.

Required qualifications

• 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.

Preferred qualifications

• Hands‑on experience with Oracle Health/Cerner Millennium, particularly back‑end system build, clinical workflow configuration, or EHR functionality and optimization.

• Previous experience as a Cerner Clinical Consultant or similar role involving clinical workflow design and system configuration.

• Clinical background, with broad clinical experience across multiple patient‑care workflows or specialties.

• Experience configuring, supporting, troubleshooting, or evaluating clinical workflows within Cerner Millennium or another enterprise EHR platform.

• Experience investigating or assessing patient‑safety issues associated with EHR system functionality, clinical workflows, software defects, or configuration‑related concerns.

• Experience with medical‑device or healthcare software complaint handling, complaint investigations, post‑market surveillance, or clinical safety assessments.

• Experience working with regulated healthcare software, including Software as a Medical Device (SaMD), and associated clinical risk or patient‑safety considerations.

• Experience with Clinical Impact Assessments, Health Hazard Evaluations, benefit‑risk assessment, CAPA, complaint investigations, or vigilance.

• Experience in acute care, medication management, laboratory, diagnostic, interoperability, or high‑acuity clinical workflows.

• Working knowledge of medical‑device or SaMD risk management and post‑market requirements.

• Experience reviewing AI‑generated documentation in a regulated environment.

Responsibilities

Key Responsibilities

• 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.

Success in the role

A successful Patient Safety Strategist produces timely, clinically sound, traceable assessments; identifies when a complaint requires deeper review; clearly documents uncertainty and evidence gaps; and helps the broader organization make defensible product‑safety and regulatory decisions.

LI-SP1

Disclaimer:

Certain U.S. based or U.S. customer or client‑facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements.

Range and benefit information provided in this posting are specific to the stated locations only

US: Hiring Range in USD from: $74,100 to $148,300 per annum. May be eligible for bonus and equity.

Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle’s differing products, industries and lines of business.

Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.

Oracle US offers a comprehensive benefits package which includes the following:

1. Medical, dental, and vision insurance, including expert medical opinion

2. Short term disability and long term disability

3. Life insurance and AD&D

4. Supplemental life insurance (Employee/Spouse/Child)

5. Health care and dependent care Flexible Spending Accounts

6. Pre‑tax commuter and parking benefits

7. 401(k) Savings and Investment Plan with company match

8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non‑overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.

9. 11 paid holidays

10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.

11. Paid parental leave

12. Adoption assistance

13. Employee Stock Purchase Plan

14. Financial planning and group legal

15. Voluntary benefits including auto, homeowner and pet insurance

As part of Oracle’s onboarding process and consistent with applicable law, US‑based employees are required to complete identity verification, which involves the collection and processing of their biometric information. Accommodations to this requirement may be granted following an individualized assessment.

About Us

Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life‑saving care. And with AI embedded across our products and services, we help customers turn that promise into a better future for all. Discover your potential at a company leading the way in AI and cloud solutions that impact billions of lives.

True innovation starts when everyone is empowered to contribute. That’s why we’re committed to growing a workforce that promotes opportunities for all with competitive benefits that support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.

We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation‑[e-mail] or by calling 1-888-404-2494 in the United States.

Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.