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    Drug Safety Physician

    Vizen Life Sciences
    0-5 years
    Not Disclosed
    India
    10 July 26, 2024
    Job Description
    Job Type: Full Time Education: BDS/MBBS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

    Position: Medical Review Specialist

    Qualifications: BDS/MBBS/MD

    Experience: Entry-Level to Experienced

    Job Description:

    As a Medical Review Specialist, you will play a crucial role in the analysis and management of Adverse Drug Reactions (ADRs) for both investigational and marketed products. Your responsibilities will include providing medical review and guidance throughout the ADR reporting cycle, writing safety sections for aggregate reports, and offering expert advice to drug safety associates. You will also participate in safety review meetings and ensure readiness for internal audits or regulatory inspections.

    Key Responsibilities:

    • Medical Review and Guidance:

      • Conduct medical review and analysis of ADR reports for investigational and marketed products.
      • Provide expert guidance during the case handling and reporting cycle.

    • Aggregate Report Preparation:

      • Write safety sections and perform benefit-risk assessments for Aggregate Reports, including PSURs, CASRs, and PADERs.

    • Drug Safety Guidance:

      • Offer medical guidance to Drug Safety Associates on drug safety matters.

    • ADR Analysis:

      • Analyze ADRs during ongoing surveillance and signal detection, performing independent risk assessments as needed.

    • Meetings and Communication:

      • Participate in safety review meetings and client discussions.
      • Maintain personal readiness for internal audits and regulatory inspections.

    Skills and Competencies:

    • Clinical Research or Pharmacovigilance Knowledge:

      • Understanding of clinical research and pharmacovigilance principles.

    • Regulatory Knowledge:

      • Ability to interpret and apply global safety regulations.

    • Presentation Skills:

      • Strong skills in presenting information clearly and effectively.

    • Analytical Skills:

      • Proficient in analyzing and solving complex problems.

    • Communication:

      • Excellent verbal and written communication skills.
      • Client-focused approach with strong organizational and prioritization abilities.

    If you have a solid background in clinical research or pharmacovigilance and are looking for a role where you can make a significant impact, we encourage you to apply for the Medical Review Specialist position.

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