Global Medical Safety Clinician

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 QUALIFICAT