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    Job · 21040850

    CHENNAI · FULLTIME

    Pharmacovigilance Associate

    ICON plc

    ICON plc

    Chennai · onsite · Posted 8d ago

    Sourced fromFoundit
    Not disclosed2–4 yrsfulltimeChennai

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    Section · 01

    About this role

    Pharmacovigilance Associate (Hands-on experience in Clinical Trial & Post Marketing case processing)

    ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

    As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

    As a Pharmacovigilance Associate at ICON, you will monitor and ensure the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information.

    What You Will Be Doing

    • Collect, assess, and process adverse event reports to ensure accuracy and timely compliance with regulatory requirements
    • Partner with cross-functional teams to address safety-related questions and support ongoing investigations
    • Maintain current knowledge of pharmacovigilance regulations, global safety guidelines, and industry standards
    • Manage safety inbox and acknowledge case receipt.
    • Perform case triage and book-in to safety database.
    • Enter case details accurately and write narratives.
    • Code events, drugs, and medical history using MedDRA/WHO-DD.
    • Apply correct product labeling and perform QC checks.
    • Finalize case processing and generate queries for follow-up
    • Knowledge of seriousness, expectedness, causality, and global reporting
    • Familiarity with reconciliation processes and aggregate reporting (PSUR/DSUR)
    • Ability to mentor new joiners and review SOPs
    • Working knowledge of SDEA and KPI/SLA basics
    • Process literature ICSRs and maintain compliance with monitoring requirements

    Must Have Criteria

    • Minimum 2 years of experience in safety background, with direct involvement in case processing
    • Solid experience in Post Marketing Surveillance/Clinical Trial case processing
    • Bachelors degree in life sciences
    • Strong analytical skills with attention to detail in data collection and reporting
    • Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders
    • A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities

    What ICON Can Offer You

    Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

    In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

    Our Benefits Examples Include

    • Various annual leave entitlements
    • A range of health insurance offerings to suit you and your family's needs.
    • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
    • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
    • Life assurance
    • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

    Visit our careers site to read more about the benefits ICON offers.

    At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. 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.

    If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

    Interested in the role, but unsure if you meet all of the requirements We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

    Are you a current ICON Employee Please click here to apply

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    Section · 02

    Skills

    QC checksMedDRASLAPost marketing surveillanceWHO-DDData CollectionKPIClinical Trial case processingSDEA

    Section · Company

    About ICON Plc

    ICON plc

    ICON plc

    Clinical Research

    4.5k+

    employees

    1990

    36 years old

    Chennai, Tamil Nadu

    India

    About

    Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

    Industries

    Clinical ResearchBiotech & Life sciencesPharma

    Employee ratings

    1,077 reviews

    4.0/ 5

    Culture

    4.1

    Career growth

    3.2

    Work-life

    4.2

    Employees rate it well for

    Work Life Balance219Work Culture153Salary111Senior Management91Career Growth80

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