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    Associate Pharmacovigilance Specialist

    Clarivate
    1-5 years
    Not Disclosed
    Noida
    10 Sept. 5, 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, 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: Associate Pharmacovigilance Specialist / Pharmacovigilance Specialist

    Location: Bangalore or Noida

    Work Mode: Hybrid

    Overview:

    We are seeking a dedicated Pharmacovigilance professional to join our team in either Bangalore or Noida. This role involves performing pharmacovigilance services, including biomedical literature monitoring, adverse event reporting, indexing, and abstracting. The ideal candidate will possess a strong understanding of scientific and medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations.

    What You Will Need:

    • Education: Master’s Degree in Life Sciences, Health Sciences, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics).
    • Experience: 1 to 5 years of experience in reviewing biomedical literature for adverse event reporting, or an equivalent combination of education and experience.
    • Skills: Proficient writing skills for creating accurate and concise summaries, and a working knowledge of biomedical terminology, drugs, and therapeutic areas.

    Key Responsibilities:

    • Literature Analysis: Critically analyze a large volume of articles from biomedical literature and internal drug safety alerts. Identify individual case safety reports (ICSRs) and other potential safety-relevant information impacting the risk-benefit and safety profile of client products, adhering to regulatory requirements and standard operating procedures.
    • Narrative Writing: Write brief narratives summarizing ICSR criteria and other potentially safety-relevant information from each article.
    • Drug Safety Review: Demonstrate a thorough understanding of client drug labels and use this knowledge effectively in safety assessments. Complete drug safety reviews in a timely, accurate, and thorough manner in line with client standards.
    • Data Tracking: Utilize a drug safety system to track all actions and assessments, ensuring an audit-ready reference history.
    • Article Selection and Indexing: Select articles relevant to client interests for inclusion in the client’s product literature database. Write accurate and detailed abstracts and create comprehensive indexes to ensure precise and complete retrieval of literature.
    • Regulatory Compliance: Ensure timely completion of indexing and abstracting tasks in accordance with regulatory submission deadlines. Stay updated on new drugs, therapeutic categories, disease entities, and changes in biomedical terminology.
    • Additional Duties: Participate in searches and terminology maintenance as per business needs and provided training.

    About the Team:

    The Pharmacovigilance team at Clarivate supports multiple global customers across all therapeutic areas. We offer a supportive work environment with personalized training and opportunities for engagement in various aspects of pharmacovigilance and customer interactions.

    Hours of Work:

    The team operates in India (Bangalore or Noida) from 11:00 AM IST to 8:00 PM IST or 9:00 AM IST to 6:00 PM IST, Monday to Friday. This role supports a hybrid work mode.

    Equal Employment Opportunity:

    At Clarivate, we are committed to providing equal employment opportunities for all individuals. We adhere to all applicable laws and regulations governing non-discrimination in employment practices.

    Apply Now:

    If you are ready to make a significant impact in pharmacovigilance and join a supportive team, apply today!

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