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    Senior Pharmacovigilance Reporting Associate

    Icon
    4+ years
    Not Disclosed
    Chennai
    10 July 15, 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

    ICON Job Role Overview

    Company Overview

    At ICON, our people set us apart. Our diverse teams enable us to become better partners to our customers and help us advance and improve patients’ lives.

    Core Values

    Our ‘Own It’ culture is driven by four key values:

    • Accountability & Delivery
    • Collaboration
    • Partnership
    • Integrity

    These values unite us as individuals and set us apart as an organization. Our vision is to deliver excellence in clinical research and be the partner of choice in drug development.

    The Role

    As a Safety Reporting Specialist, you will:

    Key Responsibilities

    • Safety Reporting:
      • Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and applicable safety information to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and ICON personnel within specified timelines.
      • Release safety reporting intelligence for expedited and periodic reports to relevant authorities within specified timelines.
    • System and Process Knowledge:
      • Maintain a comprehensive understanding of ICON's safety reporting systems, processes, and conventions.
      • Understand ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents, and manuals associated with safety reporting.
    • Project Oversight:
      • Oversee assigned projects to ensure all ICON, sponsor, and regulatory timeframes are met for safety reporting.
      • Lead safety reporting activities and ensure accountability on assigned projects.
      • Ensure accurate completion of all assigned project activities in line with ICON standards, regulatory requirements, and client contractual obligations.
    • Departmental Support:
      • Support the Safety Reporting Group management in quality and compliance metric review, finance tracking, project resource tracking, client engagement, training oversight, and CAPA oversight.
      • Collaborate with project team members, client contacts, investigators, adverse event reporters, and third-party vendors.
      • Work within multiple databases, maintaining project information or Pharmacovigilance intelligence information with timely updates.
      • Perform filing and quality control of documents submitted to the eTMF or agreed filing solution.
      • Prepare for and represent the department in audits and inspections.
    • Coaching and Mentorship:
      • Coach and mentor less experienced associates in safety reporting and related work.
    • Routine Project Activities:
      • Implement and coordinate project activities, including presentations at client or investigator meetings, responses to client inquiries, review of project requirements, maintenance activities, escalation of metrics, and budget considerations.
      • Participate in client and internal meetings, representing the Safety Reporting department for assigned projects.
      • Maintain an understanding of applicable therapeutic areas and disease states.
    • Travel:
      • Domestic and/or international travel (approximately 10%) as required.
    • Additional Activities:
      • Perform other activities as identified and requested by management.

    Candidate Requirements

    • Education:
      • Bachelor's or Master's degree in Pharmacy or Pharmacovigilance.
    • Experience:
      • 4+ years in Safety Submission & Regulatory submission.
      • Global exposure.
      • Cross-functional department exposure with team management experience.

    Benefits of Working at ICON

    • Competitive Salary Packages:
      • Regularly benchmarked against competitors.
      • Annual bonuses reflecting performance goals.
    • Health-Related Benefits:
      • Comprehensive health-related benefits for employees and their families.
    • Retirement Plans:
      • Competitive retirement plans and related benefits such as life assurance.
    • Work Environment:
      • Encouragement to fulfill a sense of purpose and drive lasting change.

    Equal Opportunity Employer

    ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    Accommodation

    If you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position due to a medical condition or disability, please let us know through the form below.

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