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Spec, PV

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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:

This position is a member of the Safety Operations team within Global Patient Safety (GPS). This position serves as a team member for individual case safety report processing and as case owner for adverse event reports to ensure timely and accurate review, processing, quality control, and reporting.

Job Responsibility:

  • Process adverse event reports from all source types including review and full data entry of adverse event reports determining seriousness, expectedness, reporter’s causality and overall event resolution
  • Ensure that the correct suspect drug is selected withing the Pharmacovigilance Safety System
  • Write narratives summarizing all relevant medical information for individual case safety reports
  • Code medical terms using standardized medical dictionaries (e.g., MedDRA)
  • Using medical expertise, ensure that all data has been entered and coded correctly in the database
  • Request case investigation to gather all required medical information, including query generation, tracking and follow up with reporters in conjunction with local affiliates
  • May perform quality checks as requested/necessary
  • May perform case clean-up as required for preparation of aggregate reports

Requirements:

  • Medical and clinical knowledge
  • Excellent oral and written communication
  • Operates effectively in a team environment
  • Ability to work independently under strict deadlines and changing priorities with some supervision
  • Ability to multi-task and prioritize changing workload on a daily basis
  • Working knowledge of worldwide and regional safety regulations
  • Ability to establish proficiency working in the Pharmacovigilance Safety System
  • Degree in nursing, pharmacy, science degree or equivalent
  • Experience in the pharmaceutical industry (Regulatory or Safety) preferred
  • 2-3 years of hospital, patient care or equivalent experience preferred

Nice to have:

  • Experience in the pharmaceutical industry (Regulatory or Safety) preferred
  • 2-3 years of hospital, patient care or equivalent experience preferred

Additional Information:

Job Posted:
January 11, 2026

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