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    Icsr Group Head ( General Manager)

    Vizen Life Sciences
    15+ years
    Not Disclosed
    Remote, USA
    10 Nov. 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, 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

    Job Title: ICSR Group Head (General Manager)
    Company: [Company Name]
    Job Type: Full-Time
    Experience: 15-20 Years
    Location: [Location]

    Job Summary:

    The ICSR Group Head (General Manager) will oversee the overall operations and quality of the ICSR teams, ensuring efficient processing of cases, including literature screening, health authority submissions, data entry, case processing, and quality assurance. This leadership position is crucial for maintaining high standards of compliance, ensuring that ICSR activities meet global regulations and internal timelines.

    Key Responsibilities:

    • Leadership & Team Management: Lead and manage the ICSR management team, ensuring efficient case intake, processing, and reporting, and provide coaching to team members including ICSR team leads, reviewers, specialists, and quality checkers.
    • Compliance & Quality Assurance: Ensure adherence to global regulations, internal procedures, and quality standards for all ICSR activities while meeting regulatory timelines.
    • Cross-Functional Coordination: Collaborate with other Pharmacovigilance (PV) functions, external vendors, and cross-functional stakeholders to ensure smooth ICSR operations, aligning processes, and resolving any issues.
    • Performance Monitoring: Track and report on ICSR metrics such as the number of ICSRs received, processed, and submitted, as well as the quality, timeliness, and compliance of each case.
    • Process Improvement: Identify, develop, and implement best practices and process improvements for ICSR operations, such as optimizing workflows and enhancing quality checks.
    • Audit & Inspection Support: Support ICSR operations during audits and inspections by ensuring audit readiness, responding to findings, and implementing corrective and preventive actions (CAPAs).

    Job Requirements:

    • Experience: 15-20 years of relevant experience in Pharmacovigilance (PV), specifically in ICSR operations.
    • Education: Master’s degree in Pharmacy, Life Sciences, or a related field.
    • Skills and Competencies:
      • In-depth knowledge of PV regulations and ICSR reporting processes.
      • Proficiency with ICSR tools and systems.
      • Expertise in quality assurance, compliance, and team management.
      • Strong communication, coordination, problem-solving, and decision-making skills.

    Apply Now

    If you are an experienced leader with a strong background in Pharmacovigilance and ICSR operations, apply now to take on a key role in enhancing the quality and efficiency of global pharmacovigilance activities.

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