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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