Pharmacovigilance Scientist - Waltham - JMD Technologies Inc.

    JMD Technologies Inc.
    JMD Technologies Inc. Waltham

    13 hours ago

    $90,000 - $145,000 (USD) per year * Pharmaceutical / Bio-tech
    Description

    Title: Senior Pharmacovigilance Scientist

    Location: Greater Waltham Area, MA (Hybrid 3 days onsite)

    Employment Type: Contract

    Status: Accepting Candidates

    About the role

    The Senior Pharmacovigilance Scientist serves as a key medical analytic and coordination partner to the Safety MD/Medical Monitor for assigned marketed and investigational products. This role leads safety surveillance, signal evaluation, and aggregate reporting activities while ensuring regulatory compliance and cross-functional collaboration.

    Key Responsibilities

    • Lead and coordinate safety surveillance, signal validation, and signal evaluation activities
    • Author and manage aggregate reports (PADER/DSUR) including vendor oversight, data analysis, and quality review
    • Perform safety data analyses and draft responses to regulatory and ad hoc safety queries
    • Support investigational programs including DSMB activities, SAE reconciliation, IB/protocol/CRF safety updates
    • Maintain compliance with evolving clinical trial and post-marketing safety regulations
    • Represent Safety in cross-functional product and governance meetings

    Qualifications

    • Minimum 5+ years of medical/scientific/pharmaceutical experience, including 3+ years in a PV Scientist role
    • Demonstrated experience in analysis, interpretation, and communication of medical/scientific data
    • Strong knowledge of pharmacovigilance, drug development, and safety regulations
    • Experience with case processing, expedited reporting rules, and safety database concepts
    • Proficiency in Argus Safety System, MedDRA, Excel, PowerPoint, Word, Business Objects
    • Advanced degree required (PharmD, RN, MD, PhD, MPH, NP)

    Compensation (MA Pay Transparency):

    • Estimated hourly range: $60–$65/hr (W-2).
    • Final rate within this range will be based on skills, experience, and interview results.
    * This salary range is an estimation made by beBee
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