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    Medical Reviewer

    Eversana
    1-2 years
    Not Disclosed
    Remote
    10 Nov. 7, 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

    Medical Reviewer (Pharmacovigilance)

    Location: Remote (U.S. Only)
    Company: EVERSANA

    About EVERSANA
    At EVERSANA, we are proud to be a Great Place to Work certified company globally. Our vision to create a healthier world drives our work every day. With over 7,000 employees worldwide, we provide next-generation commercialization services to the life sciences industry, serving more than 650 clients ranging from biotech startups to established pharmaceutical companies. Our products, services, and solutions are designed to bring innovative therapies to market and improve the lives of patients worldwide.

    We believe our diverse backgrounds, experiences, and talents help us achieve our mission, and we are committed to building an inclusive culture that reflects these values. If you are passionate about making a difference and are driven by a sense of purpose, we invite you to join us at EVERSANA.

    Position Overview

    We are seeking a Medical Reviewer to join our Pharmacovigilance (PV) team. In this role, you will be responsible for the medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs), ensuring compliance with pharmacovigilance legislation and guidelines. You will assist our clients with the safety data of clinical trials and post-marketing adverse drug reactions (ADRs), contributing to the overall safety monitoring and reporting processes.

    Key Responsibilities

    • Medical Review of Adverse Events (AEs)

      • Perform medical review of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs), including analysis of narrative content, coding, expectedness, seriousness, causality, and company summary to meet service level agreements and regulatory timelines.
      • Edit and medically review Analyses of Similar Events (AOSE) for expedited cases as required by regulatory guidelines.
      • Serve as an internal expert and consultant for the pharmacovigilance case processing teams.

    • Safety Data Analysis

      • Maintain a deep understanding of the scientific basis for therapies, drug-induced diseases, medical devices, vaccines, and the drug development process.
      • Continuously acquire and maintain knowledge of product safety profiles across therapeutic areas and the corresponding regulatory requirements.
      • Conduct process improvement activities, including the implementation of quality control processes and providing feedback to case processors on discrepancies or errors.

    • Training and Mentoring

      • Support training and mentoring for case processing/medical review personnel as required.
      • Actively contribute to the organization’s initiatives to meet business and regulatory objectives.

    • Regulatory Compliance

      • Ensure compliance with international regulatory guidelines, including FDA, ICH GCP, MHRA, PMDA, and EU Clinical Trial Directive.
      • Stay informed on medical safety and regulatory industry developments to ensure adherence to changing standards.

    Job Expectations

    • Travel: Less than 5%
    • Hours: 45 hours per week
    • This position may include additional duties as assigned.

    Education and Experience

    • Required Qualifications:

      • MBBS, MD, BDS, or MDS degree.
      • 1-2 years of experience as a Medical Reviewer for ICSRs in the pharmaceutical, biotech, or medical device industries. CRO experience is highly desirable.

    • Skills and Knowledge:

      • Strong understanding of pharmacovigilance regulations, including expertise in international guidelines (FDA, ICH GCP, MHRA, PMDA, GVP, EU Clinical Trial Directive).
      • Excellent interpersonal, organizational, and communication skills (both written and verbal).
      • Proficiency in MS Office applications (Outlook, Excel, Word, PowerPoint).

    Cultural Beliefs at EVERSANA

    • Patient Minded: We act with the patient’s best interest in mind.
    • Client Delight: We own every client experience and its impact on results.
    • Take Action: We are empowered and empower others to act now.
    • Grow Talent: We own our development and invest in the development of others.
    • Win Together: We passionately connect with anyone, anywhere, anytime to achieve results.
    • Communication Matters: We create transparent, thoughtful, and timely dialogue.
    • Embrace Diversity: We create an environment of awareness and respect.
    • Always Innovate: We are bold and creative in everything we do.

    Additional Information

    Compensation: EVERSANA offers competitive salaries and benefits, with compensation determined by experience, qualifications, and geographic location.

    Important Notice:
    We are aware of fraudulent job offers misrepresenting EVERSANA. Please be aware that we will never request personal information or payment during the hiring process. Any suspicious activity should be reported immediately to our team.

    EVERSANA is an Equal Opportunity Employer and is committed to fostering a diverse and inclusive workforce. We believe that diverse perspectives contribute to innovation and success, and we welcome applicants from all backgrounds and walks of life. Inclusion is everyone’s responsibility.

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