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Medical Reviewer

https://www.baxter.com/ Logo

Baxter

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Location:
India , Gurgaon

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Category:
Health and Beauty

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Medical Reviewer (MR) is responsible for providing medical review for individual case safety reports and ensuring appropriate medical interpretation and consistency in adverse event case assessment.

Job Responsibility:

  • Provide medical review for individual case safety reports, including: coding, seriousness, expectedness, Baxter causality assessment
  • Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment
  • Potential review of periodic documents, and product labels

Requirements:

  • Provide medical review for individual case safety reports, including: coding, seriousness, expectedness, Baxter causality assessment
  • Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment
  • Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities
  • Support the Safety Operations team, providing expertise for the case processing team for medical questions e.g., coding of events, understanding coding conventions, splitting of cases etc
  • Maintain knowledge of global regulatory authority regulations (especially FDA and EMA)
  • Contribute to the training, leadership and continuing education for all departmental staff
  • May perform benefit-risk safety analysis, including: safety surveillance activities for potential safety signals, aggregate safety data review, risk management plans and REMS, Regulatory Authority assessment reports and queries, and periodic documents, such as PSURs, PBRERs, and PADERs

Additional Information:

Job Posted:
January 24, 2026

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