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    Pv Associate/Sr Pv Associate

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    1+ years
    Not Disclosed
    India Remote
    10 Oct. 7, 2024
    Job Description
    Job Type: Part 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 Associate - Chennai, India

    ICON plc is a leading healthcare intelligence and clinical research organization. We take pride in fostering an inclusive environment that drives innovation and excellence, and we invite you to join us in our mission to shape the future of clinical development.

    We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team.

    What You Will Be Doing:

    • Review and process safety events (pre-marketing, post-marketing, medical devices, and drugs) and other medically related information according to assigned tasks and project-specific procedures.
    • Analyze abstracts and full articles to extract safety information from literature sources for both pre- and post-marketed products.
    • Generate data listings from the safety database and ensure the accuracy of the information.
    • Complete adverse event follow-ups in writing and/or by phone based on client requirements.
    • Provide input and review relevant safety tracking systems for accuracy and quality, and assist in maintaining project files.
    • Conduct safety reviews of clinical and diagnostic data as part of case processing.
    • Develop and implement the Safety Management Plan effectively and efficiently, ensuring consistency within the project.
    • Support the creation of post-marketing safety activities, including PSMF, RMP, and PBRER.
    • Collaborate with the Qualified Person for Pharmacovigilance as needed.
    • Liaise with investigational sites, reporters, and sponsors regarding safety issues.
    • Work with ICON Medical Monitors, project managers, and other departments as necessary.
    • Assist in identifying out-of-scope activities in conjunction with the Pharmacovigilance Project Lead.
    • Attend project team and sponsor meetings, including presenting the safety process at kick-off and investigator meetings.
    • Support the generation of Aggregated Safety Reports (e.g., Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports) through data retrieval and other assigned tasks.
    • Assist in interim data analysis for DMC reviews.
    • Maintain the safety database and corresponding entry guidelines, ensuring data quality through established quality control processes.
    • Support the creation of the SAE/AE reconciliation plan and assist with SAE reconciliation as per project-specific guidelines.
    • Collaborate with the Safety Scientist on signal detection and risk management activities.
    • Ensure consistency with client contracts and promptly identify out-of-scope activities.
    • Propose solutions for procedural and technical issues.
    • Assist with audits and inspections as required for assigned projects.
    • Respond to and process medical information inquiries related to adverse events and product complaints for clients' products, as per agreements with ICON.

    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 abilities.
    • Fluent in written and spoken English.
    • Ability to work effectively both independently and as part of a global team.

    What ICON Can Offer You:

    Our success is built on the quality of our people. That’s why we prioritize creating a diverse culture that rewards high performance and nurtures talent.

    In addition to a competitive salary, ICON offers a comprehensive range of benefits designed to support your well-being and work-life balance, including:

    • Various annual leave entitlements.
    • Health insurance options tailored to you and your family’s needs.
    • Competitive retirement planning offerings for long-term savings.
    • Global Employee Assistance Programme, LifeWorks, providing 24/7 access to over 80,000 professionals for support.
    • Life assurance.
    • Flexible country-specific benefits, such as childcare vouchers, bike purchase schemes, discounted gym memberships, and health assessments.

    To learn more about the benefits ICON provides, please visit our careers site.

    ICON is an equal opportunity and inclusive employer committed to providing a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    If you need reasonable accommodations due to a medical condition or disability during the application process or to perform essential job functions, please let us know.

    Interested in the role but unsure if you meet all the requirements? We encourage you to apply anyway—there’s a strong chance you’re exactly what we’re looking for at ICON, whether for this position or others.

     

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