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    Lead Medical Reviewer

    Navitas Life Sciences
    3+ years
    Not Disclosed
    Bangalore
    10 May 20, 2024
    Job Description
    Job Type: Full Time Education: MBBS/MD Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description: Lead Medical Reviewer

    We are currently seeking a Lead Medical Reviewer to join our growing team. This role involves responsibility for various Medical Review activities, including:

    Responsibilities:

    Medical Review:

    • Review all Individual Case Safety Report (ICSR) cases from Clinical Trials (CT) and Post-Marketing (PM) studies.
    • Ensure data completeness according to applicable regulations, guidelines, Standard Operating Procedures (SOPs), and project-specific guidelines.
    • Conduct review and assessment of Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) received from sites.
    • Determine regulatory reportability of cases from clinical trials within assigned therapeutic teams and across all products/sites in a timely manner.
    • Perform triage of cases, determining seriousness and relatedness across assigned products.
    • Review and verify the appropriate selection of adverse events from source documents, assign appropriate MedDRA codes for medical history, laboratory tests, and events, assess expectedness, review narratives, and edit queries as appropriate.
    • Review analysis of similar events (AOSE) listings and narratives as applicable.
    • Acquire and maintain current knowledge of the product portfolio and safety profiles across therapeutic areas.
    • Escalate complex case issues on client products to the client's medical review team as appropriate.
    • Conduct assessment of litigation cases across assigned products.
    • Identify and resolve case issues, coordinating with client therapeutic teams/sites for specific products or functional groups.
    • Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate.
    • Attend project meetings and client meetings as requested.

    Operational:

    • Ensure all training is executed timely and documented.
    • Prioritize cases according to the Safety Management Plan timelines and regulatory timelines.
    • Complete allocated cases daily.
    • Communicate with delivery leads/designee for any necessary case corrections or observed trends.

    Desirable Skills and Experience:

    • Strong understanding of medical and therapeutic terminologies.
    • In-depth knowledge of applicable global, regional, and local clinical regulatory requirements (Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines).
    • Understanding of patient safety regulatory obligations.
    • Familiarity with regulatory and pharmacovigilance guidelines.
    • Proficient in written and spoken English; additional languages are favorable.
    • Proficient with usual office software (MS Office: Word, Excel, PowerPoint).
    • Soft skills: motivation, strong communication competence, structured work approach, organizational skills, reliability, commitment, and capacity for teamwork.

     

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