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    Pharmacovigilance Reporting Associate

    Icon
    0-2 years
    Not Disclosed
    Chennai
    10 Dec. 31, 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

    Pharmacovigilance Reporting Associate
    ICON plc is a world-leading healthcare intelligence and clinical research organization. We pride ourselves on fostering an inclusive environment that drives innovation and excellence. Join us in our mission to shape the future of clinical development.

    Location: [Insert location]

    Job Description

    As a Pharmacovigilance Reporting Associate, you will be responsible for:

    • Submitting 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 project timelines.
    • Managing the release of safety reporting intelligence for expedited and periodic reports, line listings for regulatory authorities, ethics committees, and investigators in accordance with company procedures.
    • Maintaining a solid understanding of ICON’s safety reporting systems, processes, and conventions.
    • Ensuring compliance with ICON Standard Operating Procedures (SOPs) and working procedures (WPs) related to safety reporting.
    • Overseeing assigned projects to meet ICON, sponsor, and regulatory reporting timelines.
    • Taking on a lead role, ensuring accountability for safety reporting activities on assigned projects.
    • Completing all project activities accurately and in line with ICON standards, regulatory requirements, and client obligations.
    • Supporting the Safety Reporting Group management with quality and compliance metrics, finance tracking, project resource tracking, and client engagement.
    • Collaborating with project teams, client contacts, investigators, and vendors to build strong relationships across functional units.
    • Working within multiple databases to maintain up-to-date project or pharmacovigilance intelligence information.
    • Ensuring the timely filing and quality control of documents submitted to the eTMF, ensuring readiness for audits or inspections.
    • Representing the department in audits and inspections as required.
    • Keeping up to date with regulatory and safety reporting intelligence practices, procedures, and regulations.
    • Mentoring less experienced associates in safety reporting activities.
    • Coordinating routine project activities, including client and investigator meeting presentations, responses to clients, authorities, and stakeholders.
    • Traveling approximately 10% domestically or internationally, as required.

    What ICON Can Offer You:

    ICON's success depends on the quality of our people. We foster a diverse culture that rewards high performance and nurtures talent. Along with a competitive salary, ICON offers:

    • Various annual leave entitlements.
    • A range of health insurance offerings to meet you and your family’s needs.
    • Competitive retirement planning to help you plan for the future.
    • Global Employee Assistance Programme, offering 24-hour access to over 80,000 specialized professionals supporting your well-being.
    • Life assurance and flexible country-specific benefits, including childcare vouchers, bike purchase schemes, gym memberships, subsidized travel passes, and health assessments.

    At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We are committed to providing an inclusive and accessible environment for all candidates and employees.

    Interested in the role?
    If you’re unsure whether you meet all the requirements, we encourage you to apply anyway. There's a good chance you are exactly what we are looking for!

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