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    Sr. Manager, Clinical Science - Cambridge, United States - The Steely Group

    The Steely Group
    The Steely Group Cambridge, United States

    2 weeks ago

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    Description

    Job Description

    Job Description

    Quick Facts:

    • This company offers a surplus of stability for incoming hires.
    • The team is seeking hires who are qualified and ready to hit the ground running.
    • Demonstrated and recent (within 6 mo.) case processing experience is a MUST HAVE.
    • OPEN TO RELOCATION HIRES
    • This role is on-site in Cambridge, MA 3 days a week between the core hours of 10a -3p.
    • Must hold US Citizenship or a Green Card.

    This Senior Manager-level role oversees the effective delivery of and continued evolution of Pharmacovigilance (PV) activities related to the organization's clinical development programs.

    The Purpose of this Role:

    • Develops and designs pharmacovigilance processes and procedures to ensure compliance with regulatory requirements, company objectives and quality standards.
    • Evaluates internal PV processes for added high-performance and efficiencies; determines how the PV organization can positively impact the organization cross-functionally.
    • Oversees the operational pharmacovigilance (PV) activities that are outsourced to a PV Service Provider (PVSP); ensures the appropriate handling of safety information.
    • Collaborates with Quality Assurance to ensure PV compliance in the case of an FDA inspection.
    • Supports the cross-functional team i.e. clinical team, Data management team, quality team and regulatory team as required and give inputs and updates as applicable as PV representative.

    Responsibilities:

    • Develops and designs pharmacovigilance processes and procedures to ensure compliance with regulatory requirements, company objectives and quality standards.
    • Collaborates on the pharmacovigilance systems within the organization to achieve globalization of the PV function.
    • Evaluates internal PV processes for added high-performance and efficiencies; determines how the PV organization can positively impact the organization cross-functionally.
    • Oversees and directly contributes to the operational pharmacovigilance (PV) activities that are outsourced to a PV Service Provider (PVSP); ensures the appropriate handling of safety information.
    • Ensures the operational, quality and administrative aspects of Drug Safety.
    • Contributes to the development and implementation of risk management plans.
    • Identifies process improvements that contribute to the development of the organization's drug safety strategies.
    • Ensures all internal staff, external consultants and Service Providers are trained to ensure compliance with organization's SOPs, pharmaceutical industry standards and applicable regulations.
    • Collaborates with leaders and other members of organization's global pharmacovigilance teams to ensure consistency on the preparation or revision of PV agreements.

    Requirements / Qualifications:

    • Bachelor of Science degree, or the equivalent in work experience.
    • 5 years of pharmaceutical industry experience, with at least 3 years of safety/pharmacovigilance experience, or relevant clinical development and post-marketing experience within the pharmaceutical, CRO, or biotechnology industry.
    • Should be willing to do hands-on work and contribute directly to the projects assigned.
    • Experience in the review, evaluation, and interpretation of safety data.
    • Experience in preparing SAEs, and authoring individual and aggregate safety documentation.
    • Experience managing pharmacovigilance activities and building collaborative relationships with clinical research organizations (CROs), pharmacovigilance Service Providers (PVSP), and vendors.
    • Pharmacovigilance safety databases (e.g., ARIS-g, Argus).
    • MedDRA terminology and coding.
    • International Council for Harmonization (ICH) Efficacy Guidelines, good clinical practice (GCP), and good manufacturing practice (GMP) requirements.
    • Microsoft Office (Word, Excel, PowerPoint, Outlook).
    • Strong analytical, data analysis and problem-solving skills with the ability to review and comprehend statistical data.
    • Excellent communication and presentation skills.
    Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women's business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.

    Company Description

    The Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women's business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.
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