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    Pv Associate/Sr Pv Associate

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    0-2 years
    Not Disclosed
    Remote
    10 Oct. 29, 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 Opportunity: Pharmacovigilance Associate

    Company: ICON plc
    Location: Chennai, India
    Job Type: [Insert Job Type]

    Company Overview

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

    Job Summary

    We are seeking a Pharmacovigilance Associate to join our dynamic team. This role involves reviewing and processing safety events, generating data listings, and maintaining project files to ensure the highest quality of safety reporting.

    Key Responsibilities

    • Review and process safety events (pre-marketing and post-marketing) according to project-specific procedures.
    • Analyze abstracts and full articles to identify safety information for both marketed and investigational products.
    • Generate and ensure the accuracy of data listings from the safety database.
    • Complete adverse event follow-ups via writing or phone, adhering to client requirements.
    • Maintain safety tracking systems for accuracy and quality, supporting the development of the Safety Management Plan.
    • Assist in creating post-marketing safety documents, such as PSMF, RMP, and PBRER.
    • Liaise with investigational sites, reporters, and Sponsors regarding safety issues.
    • Support the generation of aggregated safety reports, including Development Safety Update Reports and IND Annual Reports.
    • Assist with interim data analysis for DMC reviews and maintain quality control in the safety database.
    • Contribute to signal detection and risk management activities alongside the Safety Scientist.
    • Support audits and inspections for assigned projects and respond to medical information inquiries.

    Your Profile

    • Experience in a Pharmaceutical or CRO environment.
    • At least 1 year of experience in pharmacovigilance.
    • Excellent verbal and written communication skills.
    • Detail-oriented with strong organizational and time management skills.
    • Ability to work effectively both independently and in a team across global settings.
    • Fluent in written and verbal English.

    What ICON Offers You

    Our success depends on the quality of our people. That’s why we prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, we offer a range of benefits designed to promote well-being and work-life balance, including:

    • Various annual leave entitlements.
    • Comprehensive health insurance options.
    • Competitive retirement planning offerings.
    • Access to a Global Employee Assistance Programme.
    • Flexible country-specific benefits, including childcare vouchers, gym memberships, and more.

    At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We are committed to providing an accessible environment for all candidates and fostering a workplace free from discrimination and harassment.

    Application Process

    If you need a reasonable accommodation for any part of the application process due to a medical condition or disability, please let us know. We encourage all interested candidates to apply, even if you don’t meet every requirement—we believe you might be exactly what we’re looking for!

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