20 days ago on edwards.taleo.net

Medical Safety Officer

Edwards Lifesciences SA

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Medical Safety Officer

%3Cdiv%3E%3Cfont face=%22Verdana%22%3EEdwards has an exciting opportunity in the Transcatheter Mitral and Tricuspid Technologies (TMTT) group, focused on developing minimally-invasive solutions for patients suffering from structural heart disease.%3C/font%3E%3C/div%3E%0A%3Cdiv%3E%3Cfont face=%22Verdana%22%3E%26nbsp;%3C/font%3E%3C/div%3E%0A%3Cdiv%3E%3Cfont face=%22Verdana%22%3EAs the Associate Manager, Clinical Safety you will ensure patient safety in clinical trials by conducting safety assessments, identifying/analyzing safety signals and trends, creating and implementing safety processes and trainings and providing clinical safety expertise.%3C/font%3E%3C/div%3E%0A%3Cdiv%3E%3Cfont face=%22Verdana%22%3E%26nbsp;%3C/font%3E%3C/div%3E%0A%3Cdiv%3E%3Cfont face=%22Verdana%22%3E%3Cb%3EJob Functions%5C:%26nbsp;%3C/b%3E%3C/font%3E%3C/div%3E%0A%3Cdiv%3E%0A%3Cul%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EConduct Sponsor assessment of adverse events/serious adverse events from clinical studies, including UADE (Unanticipated Adverse Device Effect) determinations, assessment of seriousness, device and procedure relationship and report adverse events according to regulatory requirements, trial safety processes and Edwards’ procedures.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EPrepare or review event narratives for internal review or external review (Clinical Endpoints Committee), as well as for regulatory submissions.%26nbsp;%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EDetermine whether or not an event requires formal review (CEC adjudication).%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EReview and analyze aggregate safety reports to identify early safety signals and escalate to leadership with recommended next steps.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EEvaluate the need for a change in the clinical risk/benefit analysis.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EAdvise Complaint Handling on medical aspects of reported complaint information.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3ETrain and advise Edwards and site personnel on safety reporting and appropriate support documentation.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EContribute to safety aspects of protocol design; regulatory submissions, reports, clinical summaries, updates and other%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EParticipate as a member of the cross-functional team and provide safety input to risk management documents and other cross functional documents , as needed%3C/font%3E%3C/li%3E%3C/ul%3E%3C/div%3E!|!!*!%3Cdiv%3E%3Cfont face=%22Verdana%22%3EEdwards has an exciting opportunity in the Transcatheter Mitral and Tricuspid Technologies (TMTT) group, focused on developing minimally-invasive solutions for patients suffering from structural heart disease.%3C/font%3E%3C/div%3E%0A%3Cdiv%3E%3Cfont face=%22Verdana%22%3E%26nbsp;%3C/font%3E%3C/div%3E%0A%3Cdiv%3E%3Cfont face=%22Verdana%22%3EAs the Associate Manager, Clinical Safety you will ensure patient safety in clinical trials by conducting safety assessments, identifying/analyzing safety signals and trends, creating and implementing safety processes and trainings and providing clinical safety expertise.%3C/font%3E%3C/div%3E%0A%3Cdiv%3E%3Cfont face=%22Verdana%22%3E%26nbsp;%3C/font%3E%3C/div%3E%0A%3Cdiv%3E%3Cfont face=%22Verdana%22%3E%3Cb%3EJob Functions%5C:%26nbsp;%3C/b%3E%3C/font%3E%3C/div%3E%0A%3Cdiv%3E%0A%3Cul%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EConduct Sponsor assessment of adverse events/serious adverse events from clinical studies, including UADE (Unanticipated Adverse Device Effect) determinations, assessment of seriousness, device and procedure relationship and report adverse events according to regulatory requirements, trial safety processes and Edwards’ procedures.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EPrepare or review event narratives for internal review or external review (Clinical Endpoints Committee), as well as for regulatory submissions.%26nbsp;%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EDetermine whether or not an event requires formal review (CEC adjudication).%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EReview and analyze aggregate safety reports to identify early safety signals and escalate to leadership with recommended next steps.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EEvaluate the need for a change in the clinical risk/benefit analysis.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EAdvise Complaint Handling on medical aspects of reported complaint information.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3ETrain and advise Edwards and site personnel on safety reporting and appropriate support documentation.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EContribute to safety aspects of protocol design; regulatory submissions, reports, clinical summaries, updates and other%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EParticipate as a member of the cross-functional team and provide safety input to risk management documents and other cross functional documents , as needed%3C/font%3E%3C/li%3E%3C/ul%3E%3C/div%3E!|!!*!%3Cdiv align=%22justify%22%3E%0A%3Cdiv align=%22justify%22%3E%3Cfont face=%22Verdana%22%3E%3Cb%3ERequired Education/Skills/Experience%5C:%26nbsp;%3C/b%3E%3C/font%3E%3C/div%3E%0A%3Cdiv align=%22justify%22%3E%0A%3Cul%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EAn MD (or equivalent medical degree) is required. At least 3 years of industry experience with device/drug safety or more than 3 years of clinical research experience and safety reporting is required.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EInternal medicine/cardiology/cardiac surgery preferred%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EClass III Medical Device experience preferred%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EExcellent written and verbal communication skills, presentation skills, interpersonal skills and analytical skills are a must.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3ESubstantial computer literacy.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EStrong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EUnderstanding of medical device regulatory requirements and documents, device accountability and adverse events reporting%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EAbility to communicate and relate well with key opinion leaders and clinical personnel%3C/font%3E%3C/li%3E%3C/ul%3E%3C/div%3E%3C/div%3E!|!!*!%3Cdiv align=%22justify%22%3E%0A%3Cdiv align=%22justify%22%3E%3Cfont face=%22Verdana%22%3E%3Cb%3ERequired Education/Skills/Experience%5C:%26nbsp;%3C/b%3E%3C/font%3E%3C/div%3E%0A%3Cdiv align=%22justify%22%3E%0A%3Cul%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EAn MD (or equivalent medical degree) is required. At least 3 years of industry experience with device/drug safety or more than 3 years of clinical research experience and safety reporting is required.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EInternal medicine/cardiology/cardiac surgery preferred%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EClass III Medical Device experience preferred%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EExcellent written and verbal communication skills, presentation skills, interpersonal skills and analytical skills are a must.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3ESubstantial computer literacy.%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EStrong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EUnderstanding of medical device regulatory requirements and documents, device accountability and adverse events reporting%3C/font%3E%3C/li%3E%0A%3Cli%3E%3Cfont face=%22Verdana%22%3EAbility to communicate and relate well with key opinion leaders and clinical personnel%3C/font%3E%3C/li%3E%3C/ul%3E%3C/div%3E%3C/div%3E!|!!*!%3Cp 0px??=%22%22 margin-bottom%5C:=%22%22 0px;=%22%22 margin-top%5C:=%22%22%3E%3Cfont face=%22verdana%22%3EEdwards 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%27s 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 10,000 individuals worldwide.%3C/font%3E%3C/p%3E%0A%3Cp 0px??=%22%22 margin-bottom%5C:=%22%22 0px;=%22%22 margin-top%5C:=%22%22%3E%3Cfont face=%22verdana%22%3E%3C/font%3E%26nbsp;%3C/p%3E%0A%3Cp 0px??=%22%22 margin-bottom%5C:=%22%22 0px;=%22%22 margin-top%5C:=%22%22%3E%3Cfont face=%22verdana%22%3EFor us, helping patients is not a slogan - it%27s our life%27s 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.%3C/font%3E%3C/p%3E!|!!*!%3Cp 0px??=%22%22 margin-bottom%5C:=%22%22 0px;=%22%22 margin-top%5C:=%22%22%3E%3Cfont face=%22verdana%22%3EEdwards 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%27s 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 10,000 individuals worldwide.%3C/font%3E%3C/p%3E%0A%3Cp 0px??=%22%22 margin-bottom%5C:=%22%22 0px;=%22%22 margin-top%5C:=%22%22%3E%3Cfont face=%22verdana%22%3E%3C/font%3E%26nbsp;%3C/p%3E%0A%3Cp 0px??=%22%22 margin-bottom%5C:=%22%22 0px;=%22%22 margin-top%5C:=%22%22%3E%3Cfont face=%22verdana%22%3EFor us, helping patients is not a slogan - it%27s our life%27s 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.%3C/font%3E%3C/p%3E!|!Clinical Affairs!|!Clinical Affairs!|!Europe, Middle East, Africa, Canada (EMEAC)-Switzerland!|!Europe, Middle East, Africa, Canada (EMEAC)-Switzerland!|!!|!!|!false!|!202180!|!202180!|!true!|!202180!|!false!|!Submission for the position%5C: Medical Safety Officer - (Job Number%5C: 011307)!|!false!|!202180!|!false!|!true!|!https%5C://edwards.taleo.net/careersection/jobdetail.ftl?job=011307%26lang=en!|!Medical Safety Officer!|!true!%24!ftlerrors!|!!|!descRequisition.size!|!1!|!descRequisition.nbElements!|!225!|!descRequisition.isEmpty!|!false!|!descRequisition.hasElements!|!true!|!pSessionTimeout!|!0!|!pSessionWarning!|!0!|!pBeaconBeat!|!0!|!focusOnField!|!!|!csrftoken!|!sM/xamcm3gkj+7Kop7IlaO64H7zGdnTYcZYCdbQL1zI=!|!emptyListToken!|!!|!isListEmpty!|!false!|!listCount!|!!|!displayCalloutInLegend!|!false!|!addThisRequired!|!true!|!jobboardListPageTitle!|!!|!commonDescriptionForAddThis!|!!|!alreadyAppliedColumnDisplayed!|!false!|!displayDraft!|!!|!displaymessage!|!false!|!initialHistoryPage!|!1!|!restoreInitialHistoryOnRefresh!|!false!|!applicationCandidateNo!|!!|!calloutPageDisplayed!|!false!|!descriptionLogginMandatory!|!false!|!displayAsMainHeader!|!false!|!displayListingsPerPage!|!false!|!displayUrgentNeed!|!!|!isApplicantUser!|!true!|!jobsPerPageCaption!|!Job {0} out of {1}!|!listEmptyIsApplicantUser!|!true!|!listLabels!|!!|!listLocales!|!!|!requisitionno!|!202180!|!interfaceIdForTimeZone!|!requisitionDescriptionInterface!|!isJobCartActionDisplayed!|!true!|!openDescFrom!|!default!|!serializedCriteria!|!!|!sortby!|!11!%24!requisitionDescriptionInterface!|!!|!!|!!|!!|!!|!Apply for this position online!|!Apply by Email!|!Apply to this position by email!|!Add this position to the job cart!|!!|!Job Description!|!About Edwards!|!Tell us about a friend who might be interested in this job. All privacy rights will be protected.!|!false!|!Tell us about a person who might be interested in working for our organization. All privacy rights will be protected.!|!true!|! !|!Apply for this position online!|!Apply to this position by email!|!Add this position to the job cart!|!!|!!|!!|!