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    Associate Pharmacovigilance Specialist

    Clarivate
    2+ years
    Not Disclosed
    Bangalore Noida
    10 July 19, 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 Description: Pharmacovigilance Professional

    Company: Clarivate
    Location: Bangalore or Noida, India
    Work Mode: Hybrid (Monday-Friday)

    About Us:

    The Pharmacovigilance team at Clarivate offers services to multiple global customers across all therapeutic areas. We provide a supportive working environment with personalized training and opportunities to engage in various aspects of pharmacovigilance and customer engagement.

    Role Overview:

    Pharmacovigilance professionals are responsible for performing pharmacovigilance services including biomedical literature monitoring, adverse event reporting, indexing, and abstracting. The role requires a broad knowledge of scientific and medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations.

    Key Responsibilities:

    • Literature Analysis: Critically analyze large volumes of biomedical literature and internal drug safety alerts to identify individual case safety reports (ICSRs) and other safety-relevant information impacting the risk-benefit and safety profile of products, in line with regulatory requirements and standard operating procedures.
    • Narrative Writing: Write brief narratives summarizing ICSR criteria and other safety-relevant information found in articles.
    • Drug Safety Understanding: Demonstrate understanding of client’s drug labels and apply this knowledge effectively in safety assessments.
    • Timely Review: Complete drug safety reviews of biomedical literature batches in a timely, thorough, and accurate manner, adhering to client standards.
    • System Tracking: Use the drug safety system to track all actions and assessments, ensuring an audit-ready reference history.
    • Article Selection: Select articles relevant to client’s interests for inclusion in the client’s product literature database according to guidelines.
    • Abstracting & Indexing: Write accurate, detailed abstracts of selected articles and create comprehensive indexes to ensure precise retrieval from the client’s database.
    • Regulatory Compliance: Ensure timely completion of indexing and abstracting of articles in accordance with regulatory submission deadlines.
    • Knowledge Maintenance: Stay updated on new drugs, therapeutic categories, disease entities, and changes in biomedical terminology.

    Qualifications:

    • Education: Master’s Degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.)
    • Experience: At least 2 years of experience reviewing biomedical literature for adverse event reporting or an equivalent combination of education and experience.
    • Skills: Strong writing skills for creating accurate summaries, knowledge of biomedical terminology, drugs, and therapeutic areas.

    Team Environment:

    The Pharmacovigilance team at Clarivate is dedicated to providing a collaborative and supportive environment. We offer personalized training and opportunities for professional development and engagement in various aspects of pharmacovigilance.

    Equal Opportunity:

    At Clarivate, we are committed to providing equal employment opportunities for all individuals. We adhere to applicable laws and regulations governing non-discrimination in all locations, ensuring fair treatment in hiring, compensation, promotion, training, and other employment terms and conditions.

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