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    Pharmacovigilance Specialist

    Clarivate
    2 years years
    Preffered by Company
    Noida
    Not Disclosed July 8, 2024
    Job Description
    Job Type: Full Time Education: Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology or Biophysics) or a degree in Dentistry or Bachelor degree in Veterinary Sciences (B.V.Sc.) Skills: Causality Assessment, Communication Skills, GCP guidelines, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Terminology, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    Pharmacovigilance Specialist

    Organization: Clarivate Analytics
    Job ID: JREQ128309
    Posted Date: July 8th, 2024
    Location: Available in 2 locations, Remote: Hybrid
    Department: Life Sciences & Healthcare

    Position Summary

    The Pharmacovigilance Specialist performs pharmacovigilance services including biomedical literature monitoring, adverse events reporting, indexing, and abstracting. This role requires a broad knowledge of scientific terms, medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations.

    Reports To

    • Director, Consulting
    • Senior Manager, Pharmacovigilance
    • Manager, Pharmacovigilance

    Duties and Responsibilities

    • Critical Analysis: Analyze large numbers of articles from biomedical literature and internal drug safety alerts to identify individual case safety reports (ICSRs) and other safety-relevant information.
    • Narrative Writing: Write brief narratives summarizing ICSR criteria and safety-relevant information in each article.
    • Client Drug Labels: Utilize knowledge of client’s drug labels for effective safety assessments.
    • Timeliness and Accuracy: Ensure timely, thorough, and accurate drug safety reviews in accordance with client standards.
    • Tracking: Use drug safety systems to track actions and assessments in an audit-ready reference history.
    • Article Selection: Select articles specific to client interest for inclusion in product literature databases.
    • Abstract Writing: Write accurate, detailed, and complete abstracts of selected articles with excellent organization, grammar, and syntax.
    • Indexing: Extract key points and create comprehensive indexes of abstract contents to ensure precise retrieval from databases.
    • Regulatory Deadlines: Ensure timely completion of indexing and abstracting for assigned drugs according to regulatory deadlines.
    • Continuous Learning: Stay updated on new drugs, therapeutic categories, disease entities, and biomedical terminology.
    • Additional Duties: Participate in searches, terminology maintenance, and other duties as per business needs.

    Educational Qualifications

    • Required: Master’s Degree in Life Sciences, Health, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.)
    • Advantageous: Degree in Dentistry, Physiotherapy, Nursing involving hospital-based patient exposure
    • Experience:
      • 2-4 years of experience reviewing biomedical literature for adverse event reporting, or
      • Equivalent combination of education and experience (e.g., information science degree with 2 years of relevant drug and patient safety knowledge)

    Related Experience

    • Desirable experience in drug safety/pharmacovigilance.
    • Strong analytic ability to summarize biomedical case reports and studies.
    • At least 2 years of experience in writing precise summaries.
    • Working knowledge of biomedical terminology, drugs, and therapeutic areas.

    Ancillary Qualifications

    • Certification: Professional medical writer’s association certification.
    • Databases: Experience with commercial and client-specific biomedical literature databases.
    • Writing: Scientific/medical writing background.

    Skills

    • Excellent English language skills (comprehension, speaking, reading, and writing).
    • Working knowledge of biomedical terminology, drugs, and therapeutic areas.
    • Flexibility and adaptability to changing client needs.
    • Ability to work effectively, independently, and collaboratively.
    • Basic computer literacy.

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