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    Icsr Group Head ( General Manager)

    Vizen Life Sciences
    15+ 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: ICSR Group Head (General Manager)

    Job Summary:

    The ICSR Group Head (General Manager) is responsible for overseeing the operations and quality of ICSR teams, including literature screening, HA submission, data entry, case processing, and quality assurance. This role ensures compliance with global regulations and internal procedures while managing a high-performing team.

    Responsibilities:

    • Team Leadership: Lead and manage the integrated ICSR management team, including case intake, processing, and reporting functions. Coach and develop team leads, reviewers, specialists, and quality checkers responsible for end-to-end ICSR activities from booking to submission.
    • Compliance and Quality Assurance: Ensure adherence to global regulations, internal procedures, quality standards, and timelines for ICSR activities.
    • Coordination: Collaborate with other pharmacovigilance functions, cross-functional stakeholders, external vendors, and partners to align ICSR processes, communicate requirements, and resolve issues effectively.
    • Performance Monitoring: Monitor and report on ICSR operations metrics and performance indicators, including the number of ICSRs received, processed, and submitted, as well as quality, timeliness, compliance rates, and productivity.
    • Process Improvement: Identify and implement process improvements and best practices for ICSR operations, such as optimizing workflows, standardizing procedures, and enhancing quality checks.
    • Audit and CAPA Support: Support audits, inspections, and CAPAs related to ICSR operations by preparing for audit/inspection readiness, responding to findings, and implementing corrective and preventive actions.

    Requirements:

    • Experience: 15-20 years of relevant experience in pharmacovigilance (PV) ICSR operations.
    • Education: Master’s degree in Pharmacy, Life Sciences, or a related field.
    • Skills and Competencies:
      • Comprehensive knowledge of PV regulations and guidelines.
      • Expertise in ICSR operations methodologies, reporting, documentation, and tools.
      • Strong skills in quality assurance, compliance, team management, leadership, communication, coordination, problem-solving, and decision-making.

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