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Global Medical Safety Physician

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Date: Jan 5, 2021

Location: Boston, MA, US

Company: Terumo BCT, Inc.

Job Band:  Job Band 7 (JB7) 
Annualized Pay Range:  $191,700.00 to $240,000.00 
Target Bonus on Base:  20.0%
Hiring Manager:  James Michael Kelley 
Lead Recruiter:  Beth Ann Edick 
State:  Massachusetts (US-MA) 
Country:  United States 

 

Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential.

 

JOB TITLE: GLOBAL MEDICAL SAFETY PHYSICIAN  (REMOTE POSITION)

  

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  activities.

 

ESSENTIAL DUTIES

  • Performs professional medical evaluations of medical device performance, clinical data from complaints, and impact on medical safety of products in development
  • 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 (PHA, dFEMA, pFMEA, uFEMA, RBA) 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.
  • Authors, reviews, and contributes to vigilance reports for submission/ incorporation to Quality’s Post Market-Surveillance Reports
  • Authors, reviews, and contributes to the Safety section of the Summary of Safety and Clinical Performance (SSCP).
  • Authors relevant safety, risk management, and risk-benefit sections of clinical study documents (ie, Clinical investigation plan, Investigator’s brochure)
  • 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
  • Reviews and contributes to post market clinical follow-up (PMCF) and investigator-initiated study proposals
  • Participates in relevant statistical analysis plan, and data analysis and interpretation activities
  • Authors and reviews risk-benefit assessments for investigational products
  • Reviews and contributes to project design plans and activities
  • Collaborates with cross-functional product development teams on risk minimization activities and plans
  • Provides clinical insight during product development and serves as clinical consultant for activities across organization
  • Authors, reviews, and contributes to safety-related activities for pre-market applications and other regulatory filings, as needed
  • Supports Key Opinion Leader (KOL) development, 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
    • Reviews all study team deliverables such as final narratives and clinical study reports
    • Provides medical leadership to study sites by answering investigator questions about the protocol
    • Reviews and analyze 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
  • Position reports directly to the Director, Global Medical Safety or Manager, Global Medical Safety

 

MINIMUM QUALIFICATION REQUIREMENTS

Education

Advanced graduate degree: Healthcare Professional (i.e., MD, DO, OD).

  • Preferred: MD; Training in Epidemiology, Biostatistics, Health Surveillance, Patient Safety, Medical Quality

 

Experience

  • At least 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
  • At least 2 years clinical research / academic experience
  • Preferred: 2 years pharma/biotech/medical device experience in a medical safety role
  • Preferred: 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 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
  • Possess good clinical and scientific judgement
  • Ability to critically appraise literature and perform literature search, evaluation, and assessment, as needed
  • 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 perform risk assessments
  • Ability to gather data from multiple sources and references, formulate case narratives and perform risk assessments
  • Ability to prioritize and plan effectively
  • Effective leadership, management, cross-functional team skills, self-direction, and ability to work independently
  • Strong interpersonal skills and the ability to represent the business with both internal and external contacts.
  • Knowledge and use of relevant PC software applications and skills to use them effectively.
  • Demonstrated ability to communicate effectively both verbally and in writing.
     

-Or-

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

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

International travel may be required approximately 5%

 

 This position may be based to work remotely with approval of Director, Global Medical Safety.

 

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.


Nearest Major Market: Boston

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