Rep, Clinical Safety, Clinical Affairs (Irvine, CA) THV Job at Edwards Lifesciences
Safety is first in everything we do. We are dedicated to improving the lives of patients fighting cardiovascular disease and critical illness by providing innovative products and services that meet regulatory requirements through our effective safety processes and quality system. We are passionately driven to produce remarkable results and seek team members who exhibit accountability, integrity and credibility to join us in a highly engaging, fast-paced environment. Come join a group comprised of talented individuals who move faster, act quicker and are empowered to do more as a team!
As a Clinical Safety Rep , they will review information on adverse events to allow for continuous monitoring of patient safety data in clinical trials in accordance with regulatory requirements (FDA, IRB, EC, and Other Regulatory Bodies) and with EW procedures and ethical standards. This is an essential role within the clinical safety team and an excellent opportunity to participate in a collaborative and supportive team.
Key Responsibilities
Compile and audit patient safety files for correctness and completeness to ensure all necessary clinical information and documentation in place as required by regulations, trial safety processes, and Edwards procedures
Prepare packets from source documents and submit packets for event adjudication to CEC (Clinical Event Committee), IMR (Independent Medical Reviewer) or internal review
Review adverse event notifications and case report forms received from the investigational sites in the electronic database to support Safety Officers in daily safety review. Prepare adverse event and/or complaint review forms for Safety review. Report complaints from clinical studies to Complaint Handling incorporating information from multiple sources, in accordance with regulatory requirements, trial safety processes and Edwards procedures
Reconcile data and maintain/update in-house safety tracking systems for sponsor’s review, complaint reporting, source documents collection, and adjudication process
Request source documents from study sites for event adjudication
Incidental
Minimum Qualifications
Associate degree or equivalent 2 years’ experience
Previous related working in clinical studies
Preferred Qualifications
Bachelor's Degree Preferred
Additional Talents and General Expectations:
Advanced skills in Excel are an essential function of this position
Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g iMedidata)
Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
Experience with an ERP software (e.g JDE), CTMS (Clinical Trial Management System) and Patient Tracking system preferred
Good written and verbal communication skills and interpersonal relationship skills
Substantial knowledge and understanding of Edwards policies and procedures relevant to clinical study documentation
Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g iMedidata)
Good written and verbal communications skills
Good problem-solving skills
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including inter-departmental teams
Ability to provide feedback in a professional, direct, and tactful manner
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
About Edwards Lifesciences
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 worldwide.
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.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
Please Note :
ajayjain.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, ajayjain.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
As a Clinical Safety Rep , they will review information on adverse events to allow for continuous monitoring of patient safety data in clinical trials in accordance with regulatory requirements (FDA, IRB, EC, and Other Regulatory Bodies) and with EW procedures and ethical standards. This is an essential role within the clinical safety team and an excellent opportunity to participate in a collaborative and supportive team.
Key Responsibilities
Compile and audit patient safety files for correctness and completeness to ensure all necessary clinical information and documentation in place as required by regulations, trial safety processes, and Edwards procedures
Prepare packets from source documents and submit packets for event adjudication to CEC (Clinical Event Committee), IMR (Independent Medical Reviewer) or internal review
Review adverse event notifications and case report forms received from the investigational sites in the electronic database to support Safety Officers in daily safety review. Prepare adverse event and/or complaint review forms for Safety review. Report complaints from clinical studies to Complaint Handling incorporating information from multiple sources, in accordance with regulatory requirements, trial safety processes and Edwards procedures
Reconcile data and maintain/update in-house safety tracking systems for sponsor’s review, complaint reporting, source documents collection, and adjudication process
Request source documents from study sites for event adjudication
Incidental
Minimum Qualifications
Associate degree or equivalent 2 years’ experience
Previous related working in clinical studies
Preferred Qualifications
Bachelor's Degree Preferred
Additional Talents and General Expectations:
Advanced skills in Excel are an essential function of this position
Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g iMedidata)
Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
Experience with an ERP software (e.g JDE), CTMS (Clinical Trial Management System) and Patient Tracking system preferred
Good written and verbal communication skills and interpersonal relationship skills
Substantial knowledge and understanding of Edwards policies and procedures relevant to clinical study documentation
Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g iMedidata)
Good written and verbal communications skills
Good problem-solving skills
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including inter-departmental teams
Ability to provide feedback in a professional, direct, and tactful manner
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
About Edwards Lifesciences
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 worldwide.
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.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
Please Note :
ajayjain.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, ajayjain.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.