Role Description
Under the direction/supervision of an RN, the Adverse Drug Event Nurse LPN is responsible for completing and submitting adverse drug event reports to the pharmaceutical companies or FDA, following the internal protocols within the nurse scope of practice.
Schedule: M-F 10:30-7:00pm EST (09:30-6p CST)
Essential Functions:
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Review clinical adverse event βwork in progressβ (WIP). Use internal protocols to determine if the event should be submitted per manufacturer/FDA requirements. Responsible for accurate documentation of the event to ensure all contractual/FDA requirements are met.
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Respond to manufacturer and/or internal requests when an adverse clarification is required. Responsible for tracking of these requests as well as other errors identified and notifying the leadership team accordingly.
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Ensure all applicable manufacturer trainings are completed on time and remain compliant.
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Attend manufacturer audits as required by the leadership team.
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Responsible for good housekeeping techniques, adhering to quality and production standards while complying with all applicable company, state and federal safety and environmental programs and procedures.
Qualifications
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Practical nursing degree
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Minimum of 2 years experience in a clinical setting
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Clear, active, unrestricted LPN Nursing license in your home state
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Obtain additional state LPN Nurse Licensure as required
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General PC knowledge including Microsoft Office, Internet and email
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Knowledge of pharmacy, pharmaceuticals, or healthcare business required
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Ability to work flexible work schedule
Requirements
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Works effectively across organization and fosters teamwork
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Demonstrates the ability to manage production efficiently while building strong credible working relationships with clients, patients, and internal partners
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Excellent communication skills both verbal and written
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Demonstrated knowledge of medical terminology
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Active professional affiliations and/or national certification in related clinical specialty preferred
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If working from home, internet connection must be obtained through a cable broadband or fiber optic internet service provider with speeds of at least 10Mbps download/5Mbps upload
Benefits
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Hourly rate of 25 - 38 USD, depending on relevant factors, including experience and geographic location
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Eligible to participate in an annual bonus plan
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Comprehensive range of health-related benefits including medical, vision, dental, and well-being and behavioral health programs
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401(k)
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Company paid life insurance
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Tuition reimbursement
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A minimum of 18 days of paid time off per year and paid holidays