Global Medical Safety Physician

Requisition ID:  30791  

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 PHYSICIAN

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.  Participates in the strategic planning, management, and execution of activities related to the safety and performance of investigational products that are in the early, clinical development, and post-market stages.  Functions as medical reviewer for clinical trials and provides clinical insight during product development, clinical trial design, and life cycle management activities.

ESSENTIAL DUTIES

• Performs professional medical evaluations of medical device performance, clinical data from complaints, and impact on medical safety of products in development
• Validates safety signals and leads safety signal assessments
• Searches and reviews adverse event data, literature, and other safety-relevant data for the purpose of signal surveillance, detection, and processing
• Authors risk and/or benefit-risk assessments (i.e., health hazard evaluations) for marketed products, including hazardous materials in support of materials compliance
• Authors safety assessments for multiple purposed and provides medical oversight / approval for any concern impacting potential safety of patients / donors
• Reviews, contributes, and approves risk management plans and reports, including additional risk minimization measures (PHA, dFMEA, pFMEA, uFMEA, Benefit Risk Assessment) on behalf of medical safety
• Reviews, contributes, and approves post-marketing aggregate safety reports including PSURs, PADERs, SUSARs, PBRERs, DSURs, IND annual reports and ensure consistent communication of safety topics across various regulatory safety documents for assigned products.
• Participates in clinical development plan for products to ensure clinical input and appropriate medical safety oversight
• Reviews and contributes to the development of relevant clinical study documents (i.e., Informed consent form), clinical study reports, and manuscripts
• Authors, reviews, and contributes to safety-related activities for pre-market applications, NDA, and other regulatory filings, as needed
• Authors, reviews, or contributes to medical safety communications for marketed products
• Participates in and contributes to relevant field action/ recall activities
• Engages across Clinical / Scientific Affairs, where needed, to advance product life cycle management goals

OTHER DUTIES AND RESPONSIBILITIES

• GMS Physician will perform 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
  • 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

MD or DO degree from an accredited medical school

• Preferred: MD; Two years of global safety experience in Health Surveillance, Patient Safety, Medical Quality

Experience

• Minimum 3 years clinical/hospital experience following completion of postgraduate training
  • If an MD/DO, must possess board certification, preferably in Internal Medicine, Pediatrics or Clinical Pathology
• Minimum 2 years clinical research / academic experience
• Prefer 2 years pharma/biotech/medical device experience in a medical safety role
• Prefer 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
• Knowledge and understanding of the drug/device development and lifecycle management processes
• Knowledge and understanding of biostatistics and clinical research designs
• Knowledge and understanding of translational science
• Knowledge of therapeutic areas addressed by products from Terumo Blood and Cell Technologies
• Ability to critically appraise literature and perform literature search, evaluation, and assessment, as needed
• 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 assessment

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

Certificates, Licenses, Registrations

• Board Certified
• Medical License

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.

Additional Physical Requirements

Domestic and International travel may be required up to 10%

Target Pay Range:  $128,300.00 to $160,400.00  -  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:  20.0%

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. Absent accommodation permitted by applicable law, as a condition of employment with Terumo Blood and Cell Technologies in the United States you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.