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    Drug Safety Associate

    Gss Pharma Pvt.Ltd
    0-5 years
    Not Disclosed
    Bengaluru
    10 May 15, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, 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

    Company Overview:

    GSS Pharma Pvt. Ltd is a burgeoning pharmaceutical company situated in Bangalore, India. Specializing in the manufacturing and export of finished formulations, GSS Pharma serves a diverse pharmaceutical market with a portfolio boasting over 400 formulations across various therapeutic segments, including psychotropic and controlled substances. The company is dedicated to delivering high-quality products and services, upheld by a professionally managed team of passionate individuals. Additionally, GSS Pharma provides Pharmacovigilance services to pharmaceutical companies worldwide.

    Role Description:

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

    Responsibilities:

    1. Provide support in Pharmacovigilance tasks, including assistance to QPPV, global literature monitoring, data entry and quality review, signal detection and evaluation, and preparation of regulatory documents.
    2. Prioritize cases based on day zero and seriousness, ensuring adherence to client SOP timelines.
    3. Verify data accuracy captured by case registration/import associates.
    4. Conduct duplicate checks during case processing to identify inconsistencies.
    5. Download literature reports, perform line listing, and process cases accordingly.
    6. Review and assess the validity of literature abstracts and articles for inclusion in the safety database.
    7. Perform MedDRA coding.
    8. Monitor Pharmacovigilance Risk Assessment Committee (PRAC) recommendations and update accordingly.
    9. Manage worldwide scientific Literature Management, including screening and processing of literature reports.
    10. Ensure compliance with database usage through reference to the latest SOPs and relevant manuals.
    11. Maintain compliance with regulatory and local/global SOP timelines through proactive workflow management.
    12. Represent Drug Safety during regulatory and internal inspections and audits as necessary.

    Qualifications:

    • Doctor in Pharmacy (Pharm D) with narrative, medical coding, and pharmacy skills.
    • Excellent attention to detail.
    • Knowledge of pharmacovigilance regulations and requirements.
    • Strong written and verbal communication skills.
    • Experience in Pharmacovigilance or related role is advantageous.

    This role requires a candidate with a Pharm D degree, proficient in narrative, medical coding, and pharmacy skills, along with a keen eye for detail and strong communication abilities. Experience in Pharmacovigilance or a related field is considered beneficial. 

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