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Sr Mgr Global Medical Safety

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Date: Sep 21, 2022

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  29746  

 

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 Senior Manager, Global Medical Safety

 

JOB SUMMARY

Leads the team responsible for providing direction for patient and product safety activities, including the detection and analysis of safety issues in compliance with global pharmacovigilance and regulatory requirements.  Oversees medical safety assessments, risk management strategies, and reference safety information throughout all phases of the lifecycle of our products. 

 

ESSENTIAL DUTIES

  • Establishes the strategic pathway for embedding medical safety assessments into product life cycle with GMS Management
  • Monitors the health of Medical Safety and provides metrics to management as required
  • Identifies and implements continuous improvement opportunities
  • Serves as Subject Matter Expert and Process Owner during audits and inspections and main point of contact for regulatory / compliance issues within multiple areas of responsibility
  • Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives
  • Accountable for delivery of high quality and accurate medical evaluations and opinions on significant adverse events resulting from the use of approved devices through the development of:
    • Medical safety documents such as health hazard evaluations, benefit-risk determinations, product new business case development, failure modes effects analyses, Medical Device Reports (MDR’s) and any other documents related to medical risk
    • Risk benefit analyses, quality plans, and resolution of risk-based non-conformances
    • Medical standards, policies, procedures, processes and documents that ensure compliance to applicable regulations
    • Advocates for the highest medical standards and ensures compliance to applicable regulations, standards, and /or regional requirements (ISO 13485, ISO 14971, MDD, CMDR, FDA Quality Systems Regulations)
  • Supports medical monitoring for all investigational studies of Terumo BCT devices globally by:
    • Providing resources with the appropriate medical expertise to all clinical trials
    • Contributing to strategic decisions leading to the preparation of/modifications of the clinical development plans for Terumo BCT products
  • Provide resources that can lead the development of protocols, amendments, safety management plans, final study reports, investigator brochures, investigator correspondence and submissions to regulatory bodies
  • Serves as the point of contact for Medical Safety at Product Life Cycle Management team meetings and other cross-functional team meetings
  • Coordinates with Scientific Affairs, Clinical Affairs, Quality (Complaint handling and Risk Management), Regulatory Affairs, Manufacturing Operations, Commercial, Medical Affairs, R&D, Engineering on Enterprise-wide initiatives such as project Blue Star to ensure accurate inputs into strategic and tactical Global Medical Safety activities

 

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

A Master’s degree is required with scientific background or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered

 

Experience

  • Minimum 10 years’ experience in compliance, medical safety, risk management or related areas in the medical device, pharmaceuticals or diagnostics 
  • Experience in operating in matrixed organizations and cross-functional team settings
  • Experience with regulatory compliance audits, preferred
  • Minimum of 2 years supervisory experience, preferred

 

Skills

  • Knowledge and understanding of the drug/device development and lifecycle management processes
  • Ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence 
  • Highly adaptive to meet changing business and client needs
  • Demonstrate effective leadership, management, cross-functional team skills, self-direction, and ability to work independently
  • Positive and proactive approach to identification and definition of problems, leading to timely development and implementation of solutions
  • Strong analytical and problem-solving skills
  • Project Management skills
  • 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

Travel required up to 5%

 

 

Target Pay Range:  $150,900.00 to $188,600.00  -  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:  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.


Nearest Major Market: Denver

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