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    Pharmacovigilance and Safety - Ridgefield, United States - McInnis Inc.

    McInnis Inc.
    McInnis Inc. Ridgefield, United States

    3 weeks ago

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    Description

    Job Description

    Job Description

    Pharmacovigilance and Safety

    Provide services relating to adverse event reporting with a focus on the Final Review step of case processing and any other responsibilities typically associated with, but not limited to, the outlines and responsibilities detailed below.

    • A scalable position requiring hours per week.
    • This position is Remote/Telecommute

    Education:

    • Must have MD/ DO
    • Must have a Medical license (US or equivalent)
    • Must have at least one year of post-license clinical experience.

    Responsibilities of Contractor

    • Provide personnel/resources qualified to meet deliverable expectations as more completely described in the Responsibilities and Deliverables set forth below.
    • Along with Project Manager, review all timecards and any expense reimbursements for accuracy and adherence with policies.

    Patient Safety & Pharmacovigilance Contract Physician Deliverables and Responsibilities:

    • Responsible for assessing individual clinical trials and spontaneous case reports for medical review and regulatory reporting determination.
    • Assessing seriousness, expectedness, and causality.
    • Querying for additional medical information needed to understand, analyze, and assess the case reports.
    • Writing individual case assessments.
    • Interpreting aggregate safety data as needed.
    • On an as needed basis, perform active phone follow-up on selected medically important cases on behalf of US Patient Safety & Pharmacovigilance (PSPV), in order to optimize safety data collection and analysis.
    • Scalable position requiring hours per week.

    This position is necessary for GPV to meet its corporate responsibilities to ensure all pharmacovigilance/risk management activities are performed in accordance with standard operating procedures and within regulatory timelines.

    Required Experience:

    • 5+ years industry experience in pharmacovigilance/risk management and analysis of safety data.
    • Clinical Medicine experience with more than 1+ year of patient care required.
    • Excellent written & verbal communication skills.
    • Experience performing medical review and assessment of individual case safety reports and expedited reporting required.
    • General knowledge of medical computer programs.
    • Ability to learn computer database programs

    Oncology experience is highly preferred.

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