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Terumo BCT Global Medical Safety Physician in Lakewood, Colorado

Requisition ID: 27123Annualized Pay Range:$191,700.00to$239,700.00Target Bonus on Base:20.0%At Terumo Blood and Cell Technologies, our 7,000+ global associatesproud to come to work each day, knowing that what we do impacts the lives ofpatients around the world.We make medical devices and related products that are used to collect,separate, manufacture and process various components of blood and cells.With our innovative technologies and service offerings, we touch apatient's life every second of every day and are committed to continuing toincrease the number of patients we serve.With some of the best and brightest minds in the industry, an unmatchedglobal footprint, comprehensive benefits and a distinct culture, TerumoBlood and Cell Technologies is a great place to work, grow and be part of ateam that is focused on making a difference. Consider joining our team andunlock your potential.JOB TITLE: GLOBAL MEDICAL SAFETY PHYSICIANJOB SUMMARYLeverages patient facing clinical experience and training to lead and/orparticipate in safety signal detection activities to allow signalidentification, evaluation, validation, and management for marketedproducts including individual and aggregate data analyses, interpretation ofsafety signals and trends, documentation and communication of safety risksin collaboration with key internal and external stakeholders. Usesprofessional background from prior work in clinical setting to understandcontext of medical devices on potential risks and benefits to patient(medical) safety. Participates in the strategic planning, management,and execution of activities related to the safety and performance ofinvestigational products that are in the early, clinical development, andpost-market stages. Functions as medical reviewer for clinical trials andprovides clinical insight during product development, clinical trialdesign, and life cycle management activities.ESSENTIAL DUTIESPerforms professional medical evaluations of medical device performance,clinical data from complaints, and impact on medical safety of products indevelopmentSearches and reviews adverse event data, literature, and othersafety-relevant data for the purpose of signal surveillance, detection,and processingAuthors risk and/or benefit-risk assessments (i.e., health hazardevaluations) for marketed products, including hazardous materials insupport of materials complianceAuthors safety assessments for multiple purposed and provides medicaloversight / approval for any concern impacting potential safety of patients/ donorsReviews, contributes, and approves risk management plans and reports(PHA, dFEMA, pFMEA, uFEMA, RBA) on behalf of medical safetyReviews, contributes, and approves post-marketing aggregate safety reportsincluding PSURs, PADERs, SUSARs, PBRERs, DSURs, IND annual reportsand ensure consistent communication of safety topics across various regulatorysafety documents for assigned products.Authors, reviews, and contributes to vigilance reports for submission/incorporation to Quality's Post Market-Surveillance ReportsAuthors, reviews, and contributes to the Safety section of the Summary ofSafety and Clinical Performance (SSCP).Authors relevant safety, risk management, and risk-benefit sections ofclinical study documents (ie, Clinical investigation plan,Investigator's brochure)Participates in clinical development plan for products to ensure clinicalinput and appropriate medical safety oversightReviews and contributes to the development of relevant clinical studydocuments (i.e., Informed consent form), clinical study reports, andmanuscriptsReviews and contributes to post market clinical follow-up (PMCF) andinvestigator-initiated study proposalsParticipates in relevant statistical analysis plan, and data analysis andinterpretation activitiesAuthors and reviews risk-benefit assessments for investigational productsReviews and contributes to project design plans and activitiesCollaborates with cross-functional product development teams on riskmin

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