Global Medical Safety Clinician

Terumo BCT, Inc.
life insurance, sick time, 401(k)
United States, Colorado, Lakewood
Aug 23, 2024
Requisition ID: 32204 At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients 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 a patient's life every second of every day and are committed to continuing to increase the number of patients we serve. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. JOB TITLE: GLOBAL MEDICAL SAFETY CLINICIAN JOB SUMMARY Leverages patient facing clinical experience and training to lead and/or participate in safety signal detection activities to allow signal identification, evaluation, validation, and management for marketed products including individual and aggregate data analyses, interpretation of safety signals and trends, documentation and communication of safety risks in collaboration with key internal and external stakeholders. Uses professional background from prior work in clinical setting to understand context of medical devices on potential risks and benefits to patient (medical) safety. May function as medical reviewer for clinical trials. Provides clinical insight in support of life cycle management activities. ESSENTIAL DUTIES Contributes and performs professional medical evaluations of medical device performance, clinical data from complaints, and impact on medical safety of Terumo Blood and Cells Technologies products Performs searches and reviews adverse event data, literature, and other safety-relevant data for the purpose of signal surveillance, detection, and processing Reviews and performs vigilance data collection and summaries for incorporation to Quality's Post Market-Surveillance Reports Reviews, contributes to, and may author: Risk and/or benefit-risk assessments for marketed products, including hazardous materials in support of materials compliance; Safety assessments for multiple purposes and provides medical oversight / approval for any concern impacting potential safety of patients / donors; Risk management plans and reports (PHA, dFEMA, pFMEA, uFEMA, RBA, or BRA) on behalf of medical safety Reviews and contributes to: Post-marketing aggregate safety reports (PSURs, PADERs, SUSARs, PBRERs, DSURs, IND annual reports) and ensure consistent communication of safety topics across various regulatory safety documents for assigned products; Safety section of the Summary of Safety and Clinical Performance (SSCP); Relevant safety, risk management, and risk-benefit sections of clinical study documents (i.e., Clinical investigation plan, Investigator's brochure); Development of relevant clinical study documents (i.e., Informed consent form), clinical study reports, and manuscripts; Safety-related activities for pre-market applications and other regulatory filings, as needed; Medical safety communications for marketed products May contribute to Clinical development plans for products to ensure clinical input and appropriate medical safety oversight; Post market clinical follow-up (PMCF) and investigator-initiated study proposals May collaborate with cross-functional product development teams on risk minimization activities and plans May provide clinical insight during product development and support clinical activities across organization Participates in and contributes to relevant Health Hazard Evaluations, Field action/ Recall activities Engages across Clinical / Scientific Affairs, where needed, to advance product life cycle management goals OTHER DUTIES AND RESPONSIBILITIES GMS Clinician may perform or contribute to the medical monitoring functions for clinical studies, including: Provides medical reviews of AEs/SAEs to determine device and/or study relatedness and expectedness Provides input on clinical development plans, protocol design, and risk assessments Assists in clinical data management with MedDRA and WHO DD coding, as needed Reviews all study team deliverables such as final narratives and clinical study reports as appropriate Assists with review and analysis of safety and efficacy trends for various clinical trials Serves as the medical monitor contact in study protocols to investigators and study sites to address protocol compliance issues and safety of clinical trial subjects MINIMUM QUALIFICATION REQUIREMENTS Education Degree appropriate for licensed healthcare professional (e.g.., BSN/RN, MSN/RN, Nurse Practitioner) with equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Advanced degree and training in Epidemiology, Biostatistics, Health Surveillance, Patient Safety, Medical Quality preferred. Experience At least 3 years clinical/hospital experience following completion of postgraduate training Preferred: Two years pharma/biotech/medical device experience in a medical safety role and experience in transfusion medicine, blood banking, cellular therapy, and/or apheresis Skills Knowledge and understanding of the global processes, regulations, and reporting requirements for medical device- and/or pharmaco-vigilance and risk management and minimization activities including: Signal detection, evaluation, and management; Aggregate data analysis, interpretation, and synthesis Knowledge and understanding of the drug/device development and lifecycle management processes Knowledge of therapeutic areas addressed by products from Terumo Blood and Cell Technologies Possess good clinical and scientific judgement Ability to apply medical concepts and terminology to clinical and non-clinical settings Ability to analyze various datasets, interpret results, and convey complex scientific data in a clear, concise, and understandable manner to a scientific as well as non-scientific audience Ability to gather data from multiple sources and references, formulate case narratives and perform risk assessments Effective cross-functional team skills, self-direction, and ability to work independently Knowledge and use of relevant PC software applications and skills to use them effectively. PHYSICAL REQUIREMENTS Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Target Pay Range:$83,700.00to$104,600.00 -Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data Target Bonus on Base:7.0% At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind. Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue. We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. Respect - Appreciative of others Integrity - Guided by our mission Care - Empathetic to patients Quality - Committed to excellence Creativity - Striving for innovation We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007. We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service. Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.