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    Pv Associate/Sr Pv Associate

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    1+ years
    Not Disclosed
    Remote, USA
    10 Oct. 7, 2024
    Job Description
    Job Type: Remote 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 are committed to fostering an inclusive environment that drives innovation and excellence. 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) according to assigned tasks and project-specific procedures.
    • Analyze abstracts and full articles to identify 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 data.
    • Complete adverse event follow-ups in writing and/or by phone based on client requirements.
    • Provide input and review safety tracking systems for accuracy and quality, assisting in maintaining project files.
    • Conduct safety reviews of clinical and diagnostic data as part of case processing.
    • Develop and efficiently implement the Safety Management Plan, ensuring consistency within the project.
    • Support post-marketing safety activities, including PSMF, RMP, and PBRER.
    • Collaborate with the Qualified Person for Pharmacovigilance as required.
    • Liaise with investigational sites, reporters, and/or sponsors regarding safety issues.
    • Collaborate with ICON Medical Monitors, project managers, and other departments as needed.
    • Identify out-of-scope activities in conjunction with the Pharmacovigilance Project Lead, when applicable.
    • Attend project team and sponsor meetings, including presentations of safety processes at kick-off and investigator meetings.
    • Assist in generating Aggregated Safety Reports (e.g., Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports) through data retrieval and assigned tasks.
    • Support interim data analysis for DMC reviews.
    • Maintain the safety database and corresponding entry guidelines, ensuring data quality follows established quality control processes.
    • Assist in creating the SAE/AE reconciliation plan and support SAE reconciliation according to project-specific guidelines.
    • Aid the Safety Scientist in 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.
    • Support 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, in accordance with their agreement 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 skills.
    • Fluent in written and spoken English.
    • Ability to work effectively both independently and within a team across global settings.

    What ICON Can Offer You:

    Our success depends on the quality of our people, which is why we prioritize building a diverse culture that rewards high performance and nurtures talent.

    In addition to a competitive salary, ICON provides 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 a network of over 80,000 professionals for your family's well-being.
    • Life assurance.
    • Flexible country-specific benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, and health assessments.

    For more information about the benefits ICON offers, 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 without regard to 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 regardless—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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