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    Project Lead

    Vizen Life Sciences
    10+ years
    Not Disclosed
    Remote
    10 Aug. 22, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

    Responsibilities:

    • Project Leadership: Serve as the ICSRs Project Lead for post-marketing pharmacovigilance projects, adhering to client contracts and relevant Standard Operating Procedures (SOPs) and Work Instructions (WIs).
    • Adverse Event Processing: Oversee the receipt, processing, and management of adverse event reports from various sources, including spontaneous reports and clinical trials.
    • Database Knowledge: Maintain a thorough understanding of client-specific database conventions and ensure compliance.
    • Database Reconciliation: Collaborate with internal or external partners for the reconciliation of safety databases, as needed.
    • Workflow Monitoring: Support monitoring of workflows for assigned studies/programs to ensure adherence to deadlines.
    • Safety Presentations: Draft, modify, and deliver safety presentations to both internal and external 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 departmental safety guidelines.
    • Report Scheduling: Manage automated and manual scheduling of regulatory reports in the safety database, including initial, follow-up, amendment, nullification, and downgrade reports.
    • Case Processing: Process various case types (solicited, literature, spontaneous) using Argus or similar safety databases.
    • Reporting and Metrics: Generate and review monthly status and project-specific reports, ensuring data accuracy and quality.
    • Quality Checks: Perform quality checks on case data, finalize case versions, and handle amendments or deletions as required.
    • Case Follow-Up: Conduct appropriate case follow-ups, including generating follow-up queries and clarifications.
    • Investigations and CAPAs: Investigate process or training issues, create corrective and preventive actions (CAPAs), and support remediation efforts.
    • Safety Database Updates: Support safety database updates, data migration activities, and data clean-up efforts.
    • Client and Audit Engagement: Actively participate in project team and client meetings, prepare for audits, and support audit preparation with internal, client, or regulatory bodies.

    Education and Experience:

    • Education: Master’s degree in Pharmacy (M.Pharm) or PharmD.
    • Experience: Minimum of 10 years in pharmacovigilance safety.

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