• Product Safety Specialist

    Job Locations US-MA-Watertown
    Job ID 2018-1039
  • Overview

    The Product Safety Specialist will work across the organization to ensure pharmacovigilance and adverse event reporting is appropriately monitored, tracked and responded to for multiple commercial products.

    This position will assist in development of procedures, workflows and templates to meet regulatory requirements and company objectives.

     

    Responsibilities

    • Receives and documents safety information for Marketed and Investigational Products on a day-to-day basis
    • Interacts with company professionals and pharmacovigilance to obtain and follow-up reports of possible adverse events
    • Enters or ensures the entry of information into the global safety database
    • Verifies the accuracy, completeness and validity of information for adverse event report
    • Creates, reviews and ensures distribution of regulatory reports for FDA and other regulatory health authorities
    • Has a full understanding of the products’ Company Core Data sheet, PI, and/or IB for accurate labeling.
    • Maintain proficiency in the utilization of the Product Safety Surveillance System, including MedDRA coding. 
    • Ensure the proper and timely regulatory reporting requirements are met for ICSRs and drug safety reports
    • Ensures accurate and timely submissions to regulatory authorities, co-marketing partners and affiliates within company and regulatory timeframes
    • Is familiar with and utilizes ARISg for all reporting and confirmation of successful distribution and acknowledgement
    • Performs appropriate and timely follow-up/querying according to department guidelines, including accurate and thorough documentation within the case

    Qualifications

    • Bachelor’s degree in science or related major
    • Nursing or pharmacy degree - RN, NP or RPh or PharmD desired
    • Minimum of 4 years in biotech/pharmaceutical industry
    • Minimum of 2 years in pharmaceutical drug safety (clinical trial safety/pharmacovigilance)
    • Commercial product safety experience required
    • Familiar with medical terminology and standards of patient care
    • Computer proficiency

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