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    Lead Medical Reviewer

    Navitas Life Sciences
    0-5 years
    Preffered by Company
    Bangalore
    10 Aug. 29, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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 Description: Lead Medical Reviewer

    We are seeking a skilled Lead Medical Reviewer to join our expanding team. In this role, you will oversee medical review activities, ensuring the quality and compliance of safety data across our studies. Your responsibilities will include:

    • Medical Review and Data Assessment:

      • Conducting thorough medical reviews of all Individual Case Safety Reports (ICSRs) from both clinical trials (CT) and post-marketing (PM) studies.
      • Ensuring data completeness in accordance with applicable regulations, standard operating procedures (SOPs), and project-specific guidelines.
      • Reviewing and assessing Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) received from clinical sites.
      • Determining the regulatory reportability of cases, ensuring timely and accurate reporting within the assigned therapeutic team and across all products/sites.

    • Case Management and Documentation:

      • Performing triage to evaluate the seriousness and relatedness of cases across products as assigned.
      • Reviewing and verifying the selection of adverse events from source documents, assigning appropriate MedDRA codes, and assessing expectedness.
      • Reviewing narratives and editing queries based on medical judgment to ensure clarity and accuracy.
      • Analyzing Similar Adverse Event Listings (AOSE) and narratives as needed.

    • Knowledge and Communication:

      • Maintaining up-to-date knowledge of the product portfolio and safety profiles across therapeutic areas.
      • Escalating complex case issues to the client's medical review team when appropriate.
      • Conducting assessments of litigation cases as assigned.
      • Identifying and resolving case issues, coordinating with client therapeutic teams or functional groups as necessary.
      • Communicating effectively within and across client therapeutic teams and functional management.

    • Training and Compliance:

      • Ensuring timely execution and documentation of all required training.
      • Prioritizing cases according to safety management plan timelines and regulatory requirements.
      • Completing assigned cases on a daily basis and communicating with delivery leads or designees regarding case corrections or observed trends.

    Desirable Skills and Experience:

    • Medical Knowledge:

      • Strong understanding of medical and therapeutic terminologies.
      • In-depth knowledge of global, regional, and local clinical regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
      • Familiarity with patient safety regulatory obligations and pharmacovigilance guidelines.

    • Technical Skills:

      • Proficiency in MS Office Suite (Word, Excel, PowerPoint).
      • Strong command of written and spoken English; additional languages are a plus.

    • Soft Skills:

      • Excellent communication skills with the ability to work in a structured and organized manner.
      • Reliable, committed, and motivated with strong teamwork and organizational skills.

    If you meet these qualifications and are excited about the opportunity to contribute to a dynamic team, we encourage you to apply.

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