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    safety & pharmacovigilence specialist - Cambridge, United States - Beacon Hill

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    Description

    Safety & Pharmacovigilance Specialist

    Candidate must be currently located in the DMV area

    6-month temporary to permanent position

    Location - Cambridge, MA (hybrid schedule)

    Medical experience and drug safety expertise required

    Pharm D, Nursing MD or DO

    Responsibilities

    • Perform various tasks to support clinical research, such as adverse event analysis and processing, serious adverse event reconciliation
    • Preparation of IND safety reports for FDA submission
    • Safety document and data analysis
    • Assist clinical trial sites

    Requirements

    • M.D. or D.O from an accredited institution
    • Infectious disease and/or oncology subspecialty highly preferred
    • Knowledge of GCP and ICH guidelines
    • Drug development/clinical trial experience necessary
    • Familiarity with CTC and/or MedDRA coding a plus
    • Experience in leading clinical and cross-functional teams beneficial
    • Strong oral, written, presentation, and computer skills required
    • 3+ years of experience in pharmaceutical, biotech industry, or academia

    Beacon Hill is an Equal Opportunity Employer that cherishes the richness diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to submit their applications.



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