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Safety Physician

0-2 years
Not Disclosed
10 April 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

Job Title: Safety Physician
Location: Mumbai
Category: Clinical
Job ID: 251692

Job Overview:

Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post-marketing period.

Summary of Responsibilities:

  • Undertake primary medical review of cases, including:

    • Assessment of seriousness

    • Listedness/labeling

    • Causality

    • Adverse event coding

    • Narrative review

  • Update and document daily case data and feedback in appropriate trackers/tools to support workflow management.

  • Take full responsibility for assigned deliverables ensuring:

    • Quality

    • Compliance

    • Productivity (as per SLAs and KPIs)

  • After 1 year of tenure, provide training and guidance to the case processing team on medical aspects.

  • Support aggregate and signal analysis activities as required.

  • Foster and maintain a culture of high customer service and accountability.