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    Senior Pharmacovigilance Specialist

    Clarivate
    6+ 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

    Senior Pharmacovigilance Specialist

    Location: Hybrid (Office and Remote)

    Job Summary:

    We are seeking a Senior Pharmacovigilance Specialist to join our Pharmacovigilance (PV) team. This role offers a unique opportunity to contribute to the monitoring and assessment of literature for adverse events reporting. Utilizing a deep understanding of scientific terms, medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations, you will support our team in analyzing literature citations for individual case safety reports (ICSRs) and other safety-relevant information impacting the risk-benefit profile of our clients' products.

    About You – Experience, Education, Skills, and Accomplishments:

    • Education: Master’s Degree in Life Sciences, Health Sciences, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics). A degree in Dentistry, Physiotherapy, or Nursing with patient exposure in a hospital setting is an advantage.
    • Experience: Minimum of 6 years of experience reviewing biomedical literature for adverse event reporting, or an equivalent combination of education and experience (e.g., an information science degree with at least 5 years of relevant experience in drug and patient safety). Experience in drug safety or pharmacovigilance is desirable.
    • Skills:
      • Strong analytical skills to review and summarize biomedical case reports and studies.
      • Extensive experience in creating accurate and precise summaries.
      • Proficient in biomedical terminology, drugs, and therapeutic areas.
      • Skilled in database and literature searches.
      • Excellent interpersonal, verbal, and written communication skills.
      • Ability to work collaboratively in a team environment with a client-focused approach.
      • Capable of managing multiple tasks, prioritizing workload, and maintaining attention to detail.

    Preferred Qualifications:

    • Certification from a professional medical writer’s association.
    • Experience with commercial and client-specific biomedical literature databases.
    • Background in scientific or medical writing.

    Responsibilities:

    • Literature Analysis: Critically analyze large volumes of articles from biomedical literature and internal drug safety alerts. Identify ICSRs and other potential safety-relevant information impacting the risk-benefit profile of client products, adhering to regulatory requirements and standard operating procedures.
    • Narrative Writing: Write concise narratives summarizing ICSR criteria and other relevant safety information from each article.
    • Drug Safety Review: Complete drug safety reviews of biomedical literature batches in a timely, thorough, and accurate manner according to client standards and regulatory requirements.
    • Database Management: Use drug safety systems to track all actions and assessments, ensuring an audit-ready history.
    • Indexing and Abstracting: Select articles of interest for inclusion in client product literature databases, write detailed abstracts, and create comprehensive indexes for precise literature retrieval.
    • Regulatory Compliance: Ensure timely completion of indexing and abstracting tasks in accordance with regulatory submission deadlines. Stay informed about new drugs, therapeutic categories, disease entities, and changes in biomedical terminology.

    About the Team:

    The PV Literature team supports a diverse range of customers across all therapeutic areas. We offer a supportive work environment with personalized training and opportunities for engagement in various aspects of pharmacovigilance. Team members can also participate in customer upgrade planning if desired.

    Hours of Work:

    This is a full-time permanent position, Monday through Friday.

    Equal Employment Opportunity:

    At Clarivate, we are committed to 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 the field of pharmacovigilance and join a supportive team environment, apply today!

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