Senior Patient Safety Strategist

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

• Experience in medical device, SaMD, EHR, clinical informatics, post-market surveillance, complaint handling, Quality, Regulatory Affairs, or patient-safety functions.
• 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.

Qualifications

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

The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
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.

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 escalate 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.

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