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    Icsr Project Lead

    Vizen Life Sciences
    10+ years
    Not Disclosed
    Hyderabad
    10 July 26, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: ICSRs Project Lead - Pharmacovigilance

    Responsibilities:

    • Project Leadership: Serve as the ICSRs Project Lead for post-marketing pharmacovigilance projects, adhering to client contracts and applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs).
    • Adverse Event Management: Oversee the receipt and processing of all adverse event reports from various sources, including spontaneous reports and clinical trials, for assigned projects.
    • Database Management: Maintain a thorough understanding of client-specific database conventions and support reconciliation with internal or external partners as needed.
    • Workflow Monitoring: Support workflow monitoring to ensure project deadlines are met.
    • Safety Presentations: Draft, modify, and deliver safety presentations to both external and internal stakeholders.
    • SOP and WI Development: Assist in creating and updating departmental Work Instructions (WIs) and Standard Operating Procedures (SOPs).
    • Regulatory Compliance: Ensure compliance with ICSR regulatory submission requirements according to US and international regulations, SOPs, and safety processing guidelines.
    • Scheduling Reports: Manage automated and manual scheduling of regulatory reports in the safety database, including initial, follow-up, amendment, nullification, and downgrade reports.
    • Case Processing: Handle case processing in Argus, including solicited, literature, and spontaneous cases.
    • Reporting: Generate monthly status and project-specific reports, ensuring the quality and accuracy of metrics and data.
    • Quality Checks: Perform quality checks on case data and finalize case versions.
    • Follow-Up and Amendments: Conduct case follow-ups, generate queries and clarifications, and perform case amendments or deletions as needed.
    • Investigation and CAPAs: Conduct late case investigations, propose corrective and preventive actions (CAPAs), and support process/training remediation.
    • Data Clean-Up: Support reconciliation, replenishment, and data clean-up activities.
    • Safety Database Updates: Assist with safety database updates and data migration activities.
    • Process Improvement: Investigate and address process or training issues, facilitating the creation of CAPAs and supporting remediation efforts.
    • Client and Team Liaison: Actively participate in project team and client meetings, liaise with clients as appropriate, and prepare for internal, client, or regulatory audits.

    Education and Experience:

    • Master’s Degree in Pharmacy (M.Pharm) or Doctor of Pharmacy (Pharm D).
    • Minimum of 10 years of experience in pharmacovigilance and safety.

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