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    Icsrs Project Lead

    Vizen Life Sciences
    10 years years
    Preffered by Company
    Hyderabad
    2 June 3, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/M.Pharm/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: ICSRs Project Lead
    Job ID: JOB008
    Employment Type: Full-Time
    Location: Hyderabad
    Experience Required: 10+ Years

    Job Description:
    The ICSRs Project Lead will manage post-marketed pharmacovigilance projects, ensuring compliance with client contracts and applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs).

    Key Responsibilities:

    • Perform as the ICSRs Project Lead for assigned pharmacovigilance projects.
    • Oversee the receipt and processing of all adverse event reports, whether from spontaneous sources or clinical trials.
    • Maintain knowledge of client-specific database conventions.
    • Collaborate with internal or external partners for safety database reconciliation.
    • Monitor workflow for assigned studies or programs to meet deadlines.
    • Draft, modify, and deliver safety presentations to both external and internal stakeholders.
    • Assist in developing departmental Work Instructions (WIs) and Standard Operating Procedures (SOPs).
    • Ensure ICSR regulatory submissions are compliant with both US and international regulatory reporting requirements.
    • Understand the scheduling of regulatory reports in the safety database, including initial, follow-up, amendment, nullification, and downgrade reports.
    • Experience in case processing using Argus and handling various types of cases (solicited, literature, spontaneous).
    • Generate monthly status reports and other project-specific reports, ensuring data quality and accuracy.
    • Conduct quality checks on case data and finalize case versions.
    • Manage case follow-ups, including generating queries and clarifications as needed.
    • Handle case amendments or deletions and investigate late cases to propose corrective and preventive actions.
    • Support data reconciliation, replenishment, and clean-up activities.
    • Assist with safety database updates and data migration projects.
    • Identify, investigate, and resolve process or training issues, creating corrective/preventive actions (CAPAs) as necessary.
    • Participate actively in project team and client meetings, and liaise with clients as appropriate.
    • Prepare for and participate in internal, client, or regulatory audits, and support other functional safety leads in audit preparation.

    Education and Experience:

    • M Pharmacy or Pharm D.
    • Minimum of 10 years of experience in Pharmacovigilance (PV) Safety.

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