Global Medical Safety Sr Clinician

Requisition ID:  31106  

 

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 SENIOR SCIENTIST/CLINICIAN-Nurse/Nurse Practictioner

 

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
• 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 to 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.
• Reviews and contributes to project design plans and activities
• Provides clinical insight during product development and serves as clinical consultant for activities across organization
• 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 Senior Scientist/Clinician will perform medical monitoring functions for clinical studies, including:

• • Provide medical reviews of AEs/SAEs to determine device and/or study relatedness and expectedness
  • Provide input on clinical development plans, protocol design, and risk assessments
  • Assist in clinical data management with MedDRA and WHO DD coding, as needed
  • Review all study team deliverables such as final narratives and clinical study reports
  • Serve 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

Advanced graduate degree: Healthcare Professional (i.e., PharmD, DNP, MSN, PhD).

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

 

Experience

• At least 3 years clinical/hospital experience following completion of postgraduate training
• 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