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    Pv Associate/Sr Pv Associate

    Icon
    1+ years
    Preffered by Company
    Chennai
    10 Aug. 26, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/Any 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 Title: Pharmacovigilance Associate

    Location: Chennai, India

    About ICON plc:

    ICON plc is a global leader in healthcare intelligence and clinical research. We are dedicated to fostering an inclusive environment that drives innovation and excellence in clinical development. We invite you to join our team and help us shape the future of clinical research.

    Role Overview:

    We are seeking a detail-oriented and experienced Pharmacovigilance Associate to join our dynamic team in Chennai. This role is integral to our pharmacovigilance operations, involving the review and processing of safety events, medical literature, and data management for pre-marketing and post-marketing products.

    Key Responsibilities:

    • Review and process safety events (including pre-marketing, post-marketing, medical devices, and drugs) according to project-specific procedures.
    • Analyze abstracts and full articles to extract safety information from literature for both pre and post-marketed products.
    • Generate data listings from safety databases, ensuring data accuracy.
    • Follow up on adverse events in writing and/or by phone based on client requirements.
    • Maintain and review safety tracking systems for accuracy and quality, assisting in the upkeep of project files.
    • Conduct safety reviews of clinical and diagnostic data as part of case processing.
    • Develop and maintain the Safety Management Plan, ensuring consistency within the project.
    • Support post-marketing safety activities such as PSMF, RMP, and PBRER.
    • Assist the Qualified Person for Pharmacovigilance as needed.
    • Liaise with investigational sites, reporters, sponsors, ICON Medical Monitors, project managers, and other departments as necessary.
    • Identify and address out-of-scope activities in collaboration with the Pharmacovigilance Project Lead.
    • Attend and present safety processes at project team and sponsor meetings, including 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) and interim data analysis for DMC reviews.
    • Maintain the safety database and entry guidelines, ensuring data quality through established quality control processes.
    • Support SAE/AE reconciliation plans and activities.
    • Assist the Safety Scientist in signal detection and risk management.
    • Ensure alignment of plans with client contracts and promptly identify out-of-scope activities.
    • Propose solutions for procedural and technical issues.
    • Support audits and inspections as required.
    • Respond to and process medical information inquiries, including adverse events and product complaints for clients' products.

    Qualifications:

    • At least 1 year of experience in pharmacovigilance within a pharmaceutical or CRO environment.
    • Excellent verbal and written communication skills in English.
    • Detail-oriented with strong organizational and time management skills.
    • Ability to work effectively both independently and as part of a global team.
    • Experience with safety databases and pharmacovigilance practices.

    What ICON Offers:

    At ICON, our success relies on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a comprehensive benefits package, including:

    • Various annual leave entitlements.
    • A range of health insurance options tailored to you and your family’s needs.
    • Competitive retirement planning to help you save for the future.
    • Access to the Global Employee Assistance Programme (LifeWorks) for 24-hour support from a network of specialized professionals.
    • Life assurance and flexible, country-specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, and health assessments.

    For more information about our benefits, visit our careers site.

    Equal Opportunity Statement:

    ICON is an equal opportunity employer and is 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 require accommodation due to a medical condition or disability, please let us know or submit a request here.

    Interested in this role but unsure if you meet all the requirements? We encourage you to apply regardless—your unique experience may be just what we are looking for.

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