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Edwards has a unique opportunity to join the Transcatheter Heart
Valve (THV) group, focused on developing solutions for patients
suffering from structural heart disease.
The Safety Director leads the safety assessment of the full
portfolio of THV products in clinical evaluation globally. In this
position you will develop safety strategy and for the THV products
in clinical studies including overview of safety assessments,
identifying/analyzing safety signals and trends, creating and
implementing safety processes and training's and providing clinical
safety expertise support for other departments.
This role is located in and based out of Irvine, CA
Essential Job Functions/Key Responsibilities:
Supervise safety medical officers in carrying out safety data
review and analysis and providing safety input on key regulatory or
clinical documents (CSRs, protocols, etc.).
Develops Clinical Events Committee (CEC) adjudication & Data
Safety Monitoring Board (DSMB) processes and provides ongoing
oversight of the workflow between the CEC, DSMB and Edwards as well
as between Edwards and all clinical sites.
Development and implementation of global THV Safety processes
according to regulatory requirements, Edwards SOPs and ethical
Ongoing oversight of adverse event reporting, review and timely
adjudication for THV clinical studies
Ensure appropriate oversight of the safety profile of the THV
product in clinical evaluation, including review of individual
safety cases and aggregate reports, signal detection and
evaluation, and escalated safety issues appropriately within the
Assessment of adverse event reports and analysis for clinical,
regulatory and complaint handling submissions, in compliance with
worldwide reporting requirements (e.g., expedited UADEs, aggregate
reports and other regulatory documents as requested)
Cross-function cooperation with Clinical Affairs, Regulatory
Affairs, Quality, R&D and Marketing regarding all aspects of
safety assessment of the THV Products in clinical studies and
Contribute to Safety protocol design, submissions, reports,
clinical summaries, updates and other
Represent THV on safety aspects for the product externally,
engagement with DSMBs CEC, EC, preparation for and attendance at
regulatory authority meetings, interactions with external advisers
or opinion leaders
Facilitate talent management activities to include hiring,
training, staff development and succession planning
Develop and facilitate safety training to include creation of
materials for EW team and sites
Establish CEC & DSMB adjudication and review processes and
workflows including charters and workflow between Edwards and the
CEC & DSMBs
M.D. (or equivalent OUS medical degree) is required. Will
consider advanced practice clinician (N.P. or P.A.) with strong
cardiothoracic or interventional experience.
At least 5 years of global industry experience with device/drug
safety is required or more than 10 years of industry experience
with clinical trials.
Minimum of 3 years in clinical practice
Knowledge of global safety regulations, principles of device
development and safety assessment of devices both on the market and
in clinical development is required.
Experience and knowledge of Good Clinical Practices and
Pharmacovigilance regulatory requirements in US, the EU and
globally is required.
Preferred Qualifications: In addition to meeting minimum
requirements, it would be nice to have the following:
Internal medicine/cardiology/cardiac surgery preferred
Class III Medical Device experience preferred
Pre-clinical experience a bonus!
Additional Talents and General Expectations:
Comprehensive understanding of medical terminology and
familiarity with principles of clinical assessment of ADEs
Comprehensive knowledge of medical device regulatory documents/
device accountability/ adverse events reporting including the US
Code of Federal Regulations (CFR) 820, Canadian Medical Device
Regulation (CMDR), EU Medical Device Directives, Japan PMDA Medical
Device reporting directives, and China NMPA Medical Device
Ability to communicate and relate well with members of the
Clinical Events Committee (CEC) and members of the Data Safety
Monitoring Board (DSMB), study investigators and supporting
Demonstrable excellent written and verbal communication skills,
presentation skills, interpersonal skills and analytical skills are
Must have the ability to travel up to 30% of the time, with
occasional international travel
E dwards is an Equal Opportunity/Affirmative Action employer
including protected Veterans and individuals with disabilities.
Posted 30+ Days Ago
About Us Edwards Lifesciences is the global leader in
patient-focused medical innovations for structural heart disease,
as well as critical care and surgical monitoring. Driven by a
passion to help patients, the company collaborates with the world's
leading clinicians and researchers to address unmet healthcare
needs, working to improve patient outcomes and enhance lives.
Headquartered in Irvine, California, Edwards Lifesciences has
extensive operations in North America, Europe, Japan, Latin America
and Asia and currently employs over 13,000 individuals
For us, helping patients is not a slogan - it's our life's work.
From developing devices that replace or repair a diseased heart
valve to creating new technologies that monitor vital signs in the
critical care setting, we focus on helping patients regain and
improve the quality of their life.