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    Pv Associate/Sr Pv Associate

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    1-5 years
    Not Disclosed
    Chennai
    15 June 10, 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, 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: Safety Review Specialist

    Responsibilities:

    1. Review and process safety events (pre-marketing, post-marketing, medical device, and drug) and/or other medically related information per assigned tasks and project-specific procedures.
    2. Perform review of abstracts and full articles to identify safety information from literature sources for both pre and post-marketed products.
    3. Generate data listings from the safety database and ensure the accuracy of the data.
    4. Complete adverse event follow-up in writing and/or by phone based on requirements for each Client.
    5. Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files.
    6. Perform safety review of clinical and diagnostic data as part of case processing.
    7. Develop the Safety Management Plan effectively, including specific processes to ensure consistency within the project.
    8. Support the creation of post-marketing safety activities, such as PSMF, RMP, and PBRER.
    9. Assist with identifying out-of-scope activities in conjunction with the Pharmacovigilance Project lead (as applicable).
    10. Attend project team and Sponsor meetings and teleconferences as required, including presentation of the safety process at kick-off and investigator meetings.
    11. Support the generation of Aggregated Safety Reports through data retrieval and other assigned tasks.
    12. Support interim data analysis for DMC reviews.
    13. Maintain the safety database and corresponding entry guidelines, including assurance of data quality following established quality control processes.
    14. Support creation of the SAE/AE reconciliation plan and support SAE reconciliation in accordance with this plan and other project-specific guidelines.
    15. Support Safety Scientist in signal detection and risk management activities.
    16. Propose solutions for procedural and technical issues.
    17. Support audits and inspections as required for the assigned projects.
    18. Perform other activities as identified and requested by management, including responding and processing medical information inquiries related to adverse events and product complaints for Clients' products.

    Requirements:

    • 1 years of experience in pharmaceutical industry/clinical research organization.
    • Proficient in [relevant software/tools].
    • Strong attention to detail and analytical skills.
    • Excellent communication and interpersonal abilities.

    Note: This vacancy has expired, but similar roles may be available.

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