Global Medical Safety Clinician

1 month ago

Denver, United States Joulé Full time

Title: Global Medical Safety Clinician - RN, BSN, NP
Location: Denver area - Must be local to area for hybrid schedule
Type: Direct Hire / Permanent
Salary: up to $104k salary with 7% bonus

Requirements: Must be RN, BSN, NP. Must be licensed.
Apheresis experience required.
Must have risk management, safety and regulatory experience, along with experience preparing technical documents.
Experience supporting complaints and safety evaluation for FDA and Health Canada regulations.


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


MINIMUM QUALIFICATION REQUIREMENTS
Education BSN, RN, NP required. MSN preferred.
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 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 translational science
Knowledge of therapeutic areas addressed by products from company.
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 perform risk assessments
Ability to gather data from multiple sources and references, formulate case narratives and perform risk assessments
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.
-Or- An equivalent competency level acquired through a variation of these qualifications may be considered.


Certificates, Licenses, Registrations
MUST BE LICENSED MEDICAL PROFESSIONAL IN THE STATE OF COLORADO OR HAVE AN INTERSTATE LICENSE ALLOWING MEDICAL PRACTICE IN COLORADO.

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