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Medical Reviewer

Medical Reviewer

ConfidentialGandhinagar
9 days ago
Job description

Role Overview

  • Assess and handle clinical data and case reports, particularly Suspected Unexpected Serious Adverse Reactions (SUSAR).
  • Ensure compliance with global and local procedural documents while maintaining up-to-date knowledge of marketed drugs under litigation.

Key Responsibilities

Clinical Data Review

  • Author and edit clinical and periodic report comments in the Patient Safety database.
  • Review medical sense of cases, including seriousness, coding, and associated clinical information.
  • Provide detailed follow-up information and case updates as required.
  • Query Management

  • Respond to queries from the Case Owner and detail requests for case changes.
  • Offer product-specific advice, particularly for SUSAR cases.
  • Documentation and Compliance

  • Document reviews and case comments in the Medical Review workflow (Sapphire).
  • Ensure adherence to global and local procedural documents and policies.
  • Desired Skills

  • Extensive medical knowledge with the ability to critically assess clinical data.
  • Attention to detail, analytical thinking, and strong communication skills.
  • Qualifications

  • Bachelor of Statistics, Bachelor of Technology, MBBS, MD, or MS.
  • Skills Required

    medical review , Pharmacovigilance, clinical data analysis , Case Management

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    Medical Medical • Gandhinagar