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    Pharmacovigilance Project Lead - Chennai, India - ICON plc

    ICON plc
    ICON plc Chennai, India

    1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Is the Single Point of Contact (SPOC) for the contracted Pharmacovigilance activities and assists Project Manager for project operation oversight.


    • Provide oversight and direction of all Pharmacovigilance services/ activities throughout the duration of a project (including deliverables and finances) as a Pharmacovigilance subject matter expert.
    • Primary liaison for client and project team for Pharmacovigilance services/activities (time, scope, cost, quality, resource) matters with oversight from the Project Manager.
    • Liaise with Project Manager, and other cross functional project resources, as appropriate.
    • Work with Project Manager to ensure accurate projections of units/hours (revenue and resources) and actual units/hours for all Pharmacovigilance services.
    • Assesses upcoming workload and coordinates with the Project Manager and Resource Managers for planning.
    • Provides monthly worked units for safety services and performs timely reconciliations to ensure correct life-to-date billing.
    • Actively identify and maintains out of scope log for Pharmacovigilance Services to resolution/report to Project Manager.
    • Represents Pharmacovigilance and related service updates on client and project team meetings / teleconferences.
    • Conducts regular team briefing meeting to ensure team understanding for the project requirements, key decisions and important updates.
    • Actively communicates with the client and represents Pharmacovigilance operations in teleconferences with the relevant stakeholders for the assigned projects.
    • Responsible to support Pharmacovigilance Project set-up.
    • Ensure up to date team training throughout lifecycle of the project.
    • Responsible to provide Pharmacovigilance Service input into the Project Management Plan throughout the lifecycle of the project. When assigned to a portfolio, ensures consistency of the PMP and safety documentation across all projects.
    • Oversee the development of project specific plans (i.e. Safety Management Plan)
    • Ensures delivery of high-quality Pharmacovigilance work by the project team with compliance to the agreed timelines.
    • Ensures adherence to company document filing standards and performs regular project file reviews to confirm inspection readiness.
    • Proactively identifies, resolves/mitigates through ongoing review of project progress and metrics and escalates risks and/or issues until resolution.
    • Conducts safety presentations for bid defense, start-up meetings, Investigator Meetings and other meetings as needed.
    • Provide guidance for any audit/inspection activities.
    • Monitor quality and compliance for safety deliverables and provides data metrics for inclusion in monthly project reports. Additionally assist management, as required with weekly and monthly project status reports.
    • Lead the coordination of any safety or medical information related activities.
    • Train/mentor newly hired Pharmacovigilance staff, on project specific task as requested.
    • Perform other activities as identified and requested by Pharmacovigilance management.
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