Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative …
Skills: Clinical data analytics, People management, Safety reporting, Pharmacovigilance, Project management
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As …
Skills: Clinical data management, Clinical research, EDC systems, Project management, Data analysis
Open Rank Physicist - New Grads Welcome (Irvine, CA)
Irvine, California, United States · On-site
$196k–$380k/yr
Senior$10M raised
Open Rank Physicist – Radiation Oncology (Orange County) (Exempt) (Two positions available) Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cance…
Skills: Radiation Oncology, Medical Physics, Dose Calculations, Plan Optimization, Quality Assurance
About Us Össur is a leading global provider of innovative mobility solutions that help people live a Life Without Limitations®. Significant ongoing investment in research and development has led to over 2,100 patents, aw…
Utilization Review RN - REMOTE position. This position is Part time and will work 8- hour, Day shifts. Provide prospective, retrospective, and concurrent utilization reviews for our Southern CA ministries. Conduct clinic…
Skills: Utilization Management, Clinical Review, Medical Necessity, Patient Status Determination, Negotiation
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Data engineering, Python, SQL, AI frameworks, LangGraph
Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the ca…
Skills: Customer service, Medical referrals, Authorizations, Care coordination, Microsoft Office
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: SAS programming, Clinical trial data analysis, ADaM datasets, CDISC standards, Data visualization
About Us One Medical is a primary care solution challenging the industry status quo by making quality care more affordable, accessible and enjoyable. But this isn’t your average doctor’s office. We’re on a mission to tra…
The Admissions Representative supports patients throughout the admission and registration process. This position is responsible for collecting accurate patient information, scheduling services, verifying insurance covera…
Skills: Patient registration, Insurance verification, Medical terminology, Scheduling, Data entry
Overview Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral …
Overview Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral …
Recognized by Newsweek in 2024 and 2025 as one of America's Greatest Workplaces for Diversity Make Lives Better Including Your Own. If you want to work in an environment where you can become your best possible self, join…
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Product management, Omnichannel analytics, Data science, Marketing strategy, AI/ML
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Data Governance, Semantic Architecture, Metadata Management, Master Data Management, Data Quality
Now is the time to join PDS Health. You will have opportunities to learn new skills from our team of experienced professionals. If you're ready to take your career to the next level and gain valuable experience, apply to…
Skills: Edge computing, Network engineering, Server management, Storage management, Data center operations
At Advanced Sterilization Products (ASP), we believe in the potential of every individual to contribute, innovate, and drive meaningful change. As part of our commitment to excellence, we’re seeking a dynamic and experie…
Oso Home Care is seeking an experienced, detail-oriented Intake Coordinator to join our Specialty Home Infusion Pharmacy team. Since 1984, Oso Home Care has provided comprehensive specialty home infusion pharmacy, ambula…
Job Title: Human Resources Coordinator Department: Human Resources Reports To: Human Resources Manager FLSA Status: Non-Exempt Location: Irvine, California POSITION SUMMARY The Human Resources Coordinator provides admini…
Skills: Personnel record maintenance, HR compliance, Recruiting, Onboarding, Payroll support
The Senior Manager will lead a team in managing clinical safety dashboards, ensuring regulatory-compliant safety reporting, and overseeing data reconciliation. They will also partner with cross-functional teams to translate safety requirements into technical specifications and drive process improvements.
Requirements
Candidates must have a Bachelor's degree and a demonstrated track record in people management. Preferred qualifications include experience in clinical safety or pharmacovigilance within the medical device industry and proficiency in data analytics tools like Python and BI platforms.
Full job description
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you’ll make an impact:
Own end-to-end design, validation, and maintenance of clinical safety dashboards and reports (AE/SAE trends, coding accuracy, reporting timeliness) for internal stakeholders and safety governance bodies (e.g., DSMB, Safety Review Committee)
Lead safety data reconciliation across clinical database, safety database, and central lab/vendor sources
Ensure regulatory-compliant and timely expedited/periodic safety reporting (e.g., DSURs, IND safety reports) in partnership with Pharmacovigilance/Regulatory
Manage a team responsible for safety data QC, dashboard build/maintenance, and ad hoc safety analytics requests
Partner with Biostatistics, Clinical Data Management, and Medical Safety on signal detection methodology and dashboard logic
Partner with cloud/data engineering teams to translate clinical/safety reporting needs into technical requirements (data model, refresh cadence, query performance) for dashboard consumption
Develop a robust talent development plan in alignment with functional growth strategies of the department
Develop and deliver comprehensive presentations and written communications on clinical operations and study developments to stakeholders and management
Identify issues and collaborate with appropriate team members to bring to resolution; determine root cause; recommend and lead the implementation of corrective actions, complex process development and process improvement solutions to optimize strategic imperatives
What you’ll need (Required):
Bachelor's Degree or equivalent in a related field, or equivalent work experience based on Edwards criteria
Demonstrated track record in people management, or equivalent work experience based on Edwards criteria
What else we look for (Preferred):
Experience in clinical safety/pharmacovigilance and regulatory aspects of medical device technology, or equivalent work experience based on Edwards criteria —
Proven successful project management and leadership skills with the ability to influence change
Demonstrated strong problem-solving, process improvement, analytical, and collaborative skills
Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Expert understanding of forecasting, reporting and analytics while addressing issues with impact beyond own team based on knowledge of related disciplines
Expert understanding of related aspects of processes and/or systems
Proficiency in Python (e.g., pandas, NumPy) for clinical/safety data analysis, validation, and QC, with working knowledge of web app frameworks (e.g., Flask, Streamlit, Dash) used to build or extend the safety dashboard application
Experience with a validated clinical/safety database and dashboarding/BI tools (e.g., Tableau, Power BI, Spotfire)
Familiarity with MedDRA/WHO-DD coding conventions and working knowledge of ICH-GCP safety reporting requirements
Working knowledge of cloud-hosted data architectures (AWS preferred) and data lake concepts (ingestion, ETL/ELT, data cataloging) sufficient to partner effectively with engineering teams — not expected to build pipelines personally, but must be able to translate business/safety requirements into technical specs and validate outputs
Proven expertise in MS Office Suite, SharePoint, and ability to operate general office machinery
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment
Ability to frequently interact with customers and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $139,000 to $196,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Related keywords
Clinical Data AnalyticsPharmacovigilanceSafety DashboardsRegulatory ComplianceMedical DevicePythonPandasNumPyFlaskStreamlitDashTableauPower BISpotfireMedDRAWHO-DD
Global leader in the medical device industry with a patient-focused culture of innovation
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Founded
1958
Headquarters
Irvine, CA
LinkedIn followers
435,860
Edwards Lifesciences (NYSE: EW), is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.
We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.
Contact Us
We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus
If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm.
All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
Offices: One Edwards Way, Irvine, CA 92614, US · 12050 S Lone Peak Pkwy, Draper, Utah 84020, US · 1919 Minnesota Crt, Mississauga, Ontario L5N 0C9, CA · Parque Industrial de Itabo, Carr. Sanchez, Km 18.5 Zona Franca Industrial de Haina, Haina, San Cristobal, DO · State Road 402 North, Km 1.4, Industrial Park, Añasco, 00610-1577, PR
Medical DevicesHeart ValvesSurgical MonitoringStructural Heart DiseaseHealth Care TechnologyHeart InnovationsMedical InnovationsHeart Valve TechnologiesHeart Valve TherapiesTranscatheter Mitral &Tricuspid Therapies
How many Healthcare jobs are open in Irvine, CA right now?
There are currently 1,118 open healthcare positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Irvine, CA?
Companies currently hiring include UCI Health, Edwards Lifesciences, Allergan, City of Hope, Hoag Health System, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Irvine, CA?
Yes — 194 of the 1118 open healthcare positions offer remote or hybrid work (63 remote, 131 hybrid).
How do I apply for Healthcare jobs in Irvine, CA?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.