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 10% 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 purposes 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.
- 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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