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Raritan

    Compliance Analyst - Raritan, United States - Source One Technical Solutions

    Source One Technical Solutions
    Source One Technical Solutions Raritan, United States

    2 weeks ago

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    Description

    Source One is a consulting services company currently seeking an individual to work as a consultant with a global Pharmaceutical Manufacturing Company.

    This is a fully remote position, with occasional onsite meetings that are not very frequent.

    Job Title: Aggregate Report Compliance

    Contract Duration: 12 months, potential for extension

    Location: Raritan, NJ

    W2 Hourly Pay Rate Range: $40.00 hourly

    Hours: 40 hours/week, Mon-Fri

    Remote

    Job Description:

    • Must have Pharmacovigilance and Regulatory experience in the pharmaceutical industry supporting the Aggregate Tracking Process.

    The Sr. Associate, Aggregate Report Compliance will support the oversight of the aggregate report tracking process and compliance monitoring of aggregate report submissions to Health Authorities.

    The individual will be responsible for supervising compliance, ensuring documentation is completed for late submissions to Health Authorities and generating compliance metrics and reports supporting key partners such as:

    • Office of the Chief Medical Officer (OCMO) Senior Leadership Team
    • Office of the QPPV
    • Global Regulatory Affairs
    • International Pharmacovigilance Leadership
    • Other partners across business

    Compliance metrics feed into Quality Management Reviews, Medical Safety Council Operational Compliance Committees, and other compliance review venues. The individual will drive precision and consistency of compliance metrics, innovate processes, and develop partnerships.

    Keys for success in this role include developing partnerships, supporting aggregate report tracking systems, monitoring compliance of submissions, and generating metrics.

    Other Duties:

    The individual will prioritize and ensure timely, accurate, and consistent deliverables. They will follow documented processes and procedures for compliance monitoring and metrics generation.

    Required Knowledge, Skills and Abilities:

    • Knowledge of GxP requirements
    • Global matrix environment experience
    • Excellent communication and writing skills
    • Project Management experience
    • Proficiency in Microsoft Excel and SharePoint
    • Problem-solving skills
    • Experience in high-volume work environments

    Required Minimum Education:

    Bachelor's Degree in a relevant discipline with 4 years of pharmaceutical industry experience or advanced academic degree with 2 years of industry experience.

    Required Years of Related Experience: Minimum 2 years in pharmacovigilance case processing, aggregate reporting, or PV compliance monitoring.

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