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    Medical Reviewer

    Eversana
    1+ years
    Not Disclosed
    Pune
    10 Nov. 27, 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

    Job Opportunity: Medical Reviewer at EVERSANA 🌍

    At EVERSANA, we are proud to be certified as a Great Place to Work globally. With a team of over 7,000 employees, we are dedicated to delivering next-generation commercialization services to the life sciences industry. We serve more than 650 clients, from innovative biotech start-ups to established pharmaceutical companies. Our mission is to improve the health and well-being of patients worldwide. Join us in making a meaningful impact!

    Position: Medical Reviewer
    Location: Remote (Full-time)
    Department: Clinical & Medical
    Job Family: Medical & Regulatory Affairs
    Travel: <5%
    Hours: 45 hours per week

    Job Description

    As a Medical Reviewer, your primary responsibility will be to perform medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs), ensuring compliance with pharmacovigilance (PV) legislation and supporting clients in all medical aspects of PV.

    Key Responsibilities:

    • Perform medical review of Adverse Events (AEs) and Adverse Drug Reactions (ADRs), including coding, expectedness, seriousness, causality, and summarizing company findings within agreed timelines.
    • Compose and edit Analyses of Similar Events (AOSE) for expedited cases in line with regulatory requirements.
    • Provide expert advice to case processing teams on pharmacovigilance and safety data handling.
    • Maintain expertise on product safety profiles across multiple therapeutic areas.
    • Contribute to process improvements, particularly in quality control activities.
    • Provide feedback and training to case processors and medical review staff.
    • Stay current with global medical-safety-regulatory industry developments.

    Expectations:

    • Travel: Less than 5%
    • Weekly Hours: 45 hours
    • Position Type: Full-time (Remote)

    Education and Experience:

    • MBBS/MD/BDS/MDS or equivalent.
    • 1-2 years of experience in medical review for ICSRs in pharmaceutical, biotech, medical devices, or CROs (preferred).
    • Knowledge of international regulatory guidelines (FDA, ICH GCP, MHRA, PMDA, GVP, EU Clinical Trial Directive).
    • Strong interpersonal, organizational, and communication skills.
    • Proficiency in MS Office (Outlook, Excel, Word, PowerPoint).

    Why EVERSANA?

    • Join a global leader in life sciences commercialization.
    • Work in a diverse and inclusive culture with a strong emphasis on employee well-being.
    • Contribute to improving patient lives worldwide.

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