Medical Reviewer Job at Baxter (Gurgaon)

Medical Reviewer

Baxter

Location:
India , Gurgaon

Category:
Health and Beauty

Contract Type:
Not provided

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 are applied to 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
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

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
Potential review of periodic documents, and product labels
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 25, 2026

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Job Link Share:

Medical Reviewer

Baxter

Location:
India , Gurgaon

Category:
Health and Beauty

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 25, 2026

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