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    Medical Reviewer

    Eversana
    1-2 years
    Not Disclosed
    Boston
    10 Sept. 30, 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

    Company Description
    At EVERSANA, we take pride in being recognized as a Great Place to Work globally. Our mission is to create a healthier world, supported by a dedicated team of over 7,000 employees committed to delivering next-generation commercialization services for the life sciences industry. We partner with more than 650 clients, ranging from innovative biotech startups to established pharmaceutical companies, to bring groundbreaking therapies to market and support the patients who rely on them. Our unique skills and talents come together to make a meaningful impact every day. Join us!

    We embrace diversity in backgrounds and experiences, understanding that improving patient lives worldwide requires a team from all walks of life. We are committed to cultivating an inclusive culture that reflects our core beliefs. We seek team members who are not only skilled in their roles but also deeply invested in EVERSANA, our clients, and, most importantly, the patients we serve.

    Job Description

    Position: Medical Reviewer

    Key Responsibilities:

    • Conduct medical reviews of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including narrative content, coding, expectedness, seriousness, and causality, ensuring compliance with service level agreements and regulatory timelines.
    • Compose, edit, and review Analyses of Similar Events (AOSE) for expedited cases according to regulatory requirements.
    • Serve as an internal consultant to pharmacovigilance case processing teams on supported projects.
    • Maintain a deep understanding of the scientific foundations of therapies, drug-induced diseases, medical devices, vaccines, and the drug development process.
    • Stay current on product portfolios and safety profiles across therapeutic areas.
    • Engage in process improvement initiatives, including implementing quality control processes.
    • Provide timely feedback to case processors regarding errors or discrepancies identified.
    • Assist in the training and mentoring of other case processing and medical review personnel as needed.
    • Participate in organizational activities that align with role objectives.
    • Stay informed about developments in medical safety and regulatory affairs.

    Expectations:

    • Travel: <5%
    • Work Hours: 45 hours per week

    This role encompasses a range of responsibilities that are not limited to the items listed above.

    Education and Experience:

    • MBBS/MD/BDS/MDS required.
    • 1-2 years of experience as a Medical Reviewer for Individual Case Safety Reports (ICSRs) in pharmaceutical, biotech, or medical device settings; CRO experience is highly desirable.
    • Expertise in regulatory guidelines, including international and country-specific regulations (e.g., FDA, ICH GCP, MHRA, PMDA, GVP Modules, EU Clinical Trial Directive).
    • Excellent interpersonal and organizational skills, alongside strong written and verbal communication abilities.
    • Proficient in MS Office applications (Outlook, Excel, Word, PowerPoint, etc.).

    Additional Information:
    All information will be kept confidential according to EEO guidelines.

    Fraud Awareness:
    Be cautious of recent fraudulent job offers misrepresenting EVERSANA. Recruitment fraud often occurs through fake websites or unsolicited communications asking for personal information or payment. Please note that EVERSANA will never request personal information or fees during the hiring process.

    Diversity, Equity & Inclusion:
    Diversity, equity, and inclusion are fundamental to our success at EVERSANA. We are an Equal Opportunity Employer, welcoming individuals with diverse strengths, experiences, and backgrounds who share our commitment to improving patient lives and driving innovation in healthcare. Inclusion is a collective responsibility, and every employee’s perspective contributes to our success.

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