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    Drug Safety Associate

    Gss Pharma Pvt.Ltd
    0-5 years
    Not Disclosed
    Bengaluru
    12 June 3, 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, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Drug Safety Associate

    Company Description:

    GSS Pharma Pvt. Ltd is an emerging pharmaceutical company based in Bangalore, India. Focused on manufacturing and exporting finished formulations, GSS Pharma offers over 400 formulations in various therapeutic segments, including psychotropic and controlled substances. The company is committed to delivering quality products and services with a professionally managed team of passionate individuals. Additionally, GSS Pharma provides Pharmacovigilance services to pharmaceutical companies worldwide.

    Role Description:

    Position: Drug Safety Associate
    Type: Full-time, On-site
    Location: Bangalore Urban, India

    The Drug Safety Associate will be responsible for tasks related to Pharmacovigilance, including assisting the Qualified Person for Pharmacovigilance (QPPV), global literature monitoring, data entry and quality review, signal detection and evaluation, and preparation of regulatory documents.

    Key Responsibilities:

    • Detailed knowledge about current global pharmacovigilance guidelines and procedures.
    • Prioritize cases according to day zero and seriousness, ensuring cases are completed within the timelines mentioned in client SOP.
    • Verify the accuracy of data captured by case registration/import associate.
    • Perform duplicate checks during case processing to identify any inconsistency.
    • Download literature reports, line listings, and process these cases.
    • Review and assess the validity of literature abstracts and articles, processing them into the safety database if required.
    • Download Individual Case Study Reports (ICSR), line listings, and process these cases.
    • Perform MedDRA coding.
    • Monitor Pharmacovigilance Risk Assessment Committee (PRAC) recommendations and update accordingly.
    • Manage worldwide scientific literature, including screening and processing literature reports.
    • Ensure compliance with database usage through the latest SOPs and relevant manuals.
    • Maintain compliance with regulatory and local/global SOP timelines through proactive workflow management.
    • Represent Drug Safety in regulatory and internal inspections and audits as required.

    Qualifications:

    • Doctor in Pharmacy (Pharm D).
    • Skills in Narrative, Medical Coding, and Pharmacy.
    • Excellent attention to detail.
    • Knowledge of pharmacovigilance regulations and requirements.
    • Strong written and verbal communication skills.
    • Experience in Pharmacovigilance or a related role is a plus.

    About GSS Pharma Pvt. Ltd:

    GSS Pharma Pvt. Ltd is dedicated to delivering quality pharmaceutical products and services. The company's comprehensive approach includes a focus on manufacturing, exporting, and providing Pharmacovigilance services, all managed by a team of passionate professionals.

    If you are passionate about contributing to the pharmaceutical industry and meet the qualifications, we encourage you to apply for the Drug Safety Associate position at GSS Pharma Pvt. Ltd. Join us in our commitment to excellence in healthcare.

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