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Medical Safety Analyst Global

Date: Aug 19, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  23417  

 

JOB TITLE: GLOBAL MEDICAL SAFETY ANALYST

 

JOB SUMMARY

Performs an array of routine and ad hoc post-market surveillance tasks with a focus on identifying adverse events related to marketed products using traditional and non-traditional health data sources (e.g., clinical and administrative datasets and databases). Identifies known residual and emerging health risks and monitors the causes and conditions resulting in adverse health effects relevant to the lifecycle management of marketed products by developing and maintaining multiple internal and public-facing local, national, and global health surveillance, medical device, pharmaco- and hemovigilance systems using various analytical and reporting tools (e.g., SAS, SQL). Participates in the monitoring, reporting, investigation and analysis of adverse events related to the donation, processing and transfusion of blood products (ie., hemovigilance).

ESSENTIAL DUTIES

  • Manages safety and relevant data collection tools including safety surveillance databases, clinical, blood bank, and/or patient registries and data storage repositories to ensure data integrity and accuracy
  • Conducts data validation, auditing, and reporting on a regular, predetermined basis.
  • Conducts data mining/extraction and manipulation to generate datasets and performs relevant analyses using statistical tools and methods to support and facilitate safety signal identification, generation, and analysis activities for marketed products
  • Consults with internal and external analytic stakeholders to lead and support in-depth safety analyses including gathering informational and business needs, defining analytic plans and business requirements, conducting statistical analyses, and summarizing findings in relevant reports and presentations (ie, hemovigilance reports).
  • Collaborates with relevant internal cross-functional teams and external partners to improve analytic capacity and capability by developing shared quality improvement and population health business intelligence tools.
  • Assists in the ongoing data collection of metrics for the department related to business performance measures
  • Participates in relevant safety data analysis and interpretation activities for PMCF studies, clinical investigations, and investigator-initiated studies
  • Authors data analysis and summary reports on a regular predetermined and as needed basis for incorporation into aggregate safety reports and other relevant documents (SSCPs, CERs)
  • Searches and reviews adverse event data, literature, and other safety-relevant data for the purpose of signal surveillance, detection, and processing
  • Ensures the effective and accurate collection, recording, review and reporting of safety-related information from literature searches for signal detection and processing on a regular pre-determined basis

OTHER DUTIES AND RESPONSIBILITIES

  • Position will report directly to the Senior Manager, Global Medical Safety

 

MINIMUM QUALIFICATION REQUIREMENTS

Education

Master’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

  • Masters in a clinical-research related field of discipline (ie, MPH, MS Clinical/Health Informatics) preferred.
  • Preferred:Training in Epidemiology, Biostatistics, Health Surveillance

 

Experience

  • At least 2 years experience with health data mining, database management, and research dataset generation
  • At least 2 years experience working with clinical registries, public health surveillance systems
  • Preferred: 2 years pharma/biotech/medical device experience in a medical safety role

 

Skills

  • Ability to create and manage research datasets from patient registries, health surveillance systems, clinical data repositories, and other primary and secondary data collection tools
  • 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 and formulate summary reports
  • Ability to identify major data trends, prepare graphs and measurement tools as appropriate, and report variances
  • Strong analytical and problem-solving skills
  • Knowledge and understanding of the processes, regulations, and reporting requirements for medical device- and/or pharmaco-vigilance and risk management and minimization activities including:
    • Signal detectin, evaluation, and management
    • Aggregate data analysis, interpretatin, and synthesis
  • Knowledge and understanding of the drug/device development and lifecycle management processes
  • Ability to critically appraise literature and perform literature search, evaluation, and assessment, as needed
  • Excellent organizational, written and verbal communication skills
  • Ability to prioritize and plan effectively
  • Ability to work independently and collaboratively
  • Competent in Microsoft Office
  • Proficient in SAS and relevant research software

-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.

 

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 BCT is committed to providing a safe and secure working environment.  We maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification checks.  To this end, all employment offers for positions in the U.S. are conditional upon successful completion of Terumo BCT's pre-employment screening process.  As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers.


Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

 

As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.

 

Our company has almost $1B in annual revenues and has been voted and recognized as:

  • Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
  • Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
  • One of Colorado’s Healthiest Employers by Denver Business Journal (2014 & 2015)
  • Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015

 

Our award-winning culture embraces:

  • Leading technology through innovation and R&D
  • Wellness programs
  • Commitment to quality
  • An environment that values, respects and rewards your individual contributions
  • A philosophy of intentional growth and responsiveness to world health issues

 

Click Here to see what our associates have to say about our culture.

 

Each associate has a positive impact on our future by:

  • Connecting to the lives of the patients we ultimately serve
  • Growing through professional and leadership development activities
  • Sharing company success through incentive plans

 

If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.


Nearest Major Market: Denver

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