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    Pv Associate/Sr Pv Associate

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    0-5 years
    Not Disclosed
    Chennai
    10 Aug. 8, 2024
    Job Description
    Job Type: Full Time 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

    About the Role

    • Review and process safety events (pre-marketing, post-marketing, medical devices, and drugs) and other medically related information per assigned tasks and project-specific procedures.
    • Review 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, ensuring the accuracy of the data.
    • Complete adverse event follow-up in writing and/or by phone based on each client's requirements.
    • Provide input and review relevant safety tracking systems for accuracy and quality, and assist with maintaining project files.
    • Perform safety review of clinical and diagnostic data as part of case processing.
    • Develop and ensure the consistency of the Safety Management Plan, including specific processes within the project.
    • Support the creation of post-marketing safety activities, such as the Pharmacovigilance System Master File (PSMF), Risk Management Plan (RMP), and Periodic Benefit-Risk Evaluation Report (PBRER).
    • Provide support to the Qualified Person for Pharmacovigilance as required.
    • Liaise with investigational sites, reporters, and Sponsors regarding safety issues.
    • Collaborate with ICON Medical Monitor, project manager, and other departments as appropriate.
    • Assist in identifying out-of-scope activities in conjunction with the Pharmacovigilance Project Lead (as applicable).
    • Attend project team and Sponsor meetings and teleconferences as required, 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, and other cumulative safety reports) through data retrieval and other assigned tasks.
    • Support interim data analysis for Data Monitoring Committee (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 perform SAE reconciliation in accordance with this plan and other project-specific guidelines.
    • Assist Safety Scientists in signal detection and risk management activities.
    • Ensure consistency 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 for assigned projects.
    • Perform other activities as identified and requested by management, including:
      • Responding to and processing medical information inquiries, including those related to adverse events and product complaints for clients’ products, as per their agreement with ICON.

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