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Senior Physician, Patient Safety

India · Job Posted June 14, 2026
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Job Responsibility

  • Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
  • Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
  • Communicating and discussing issues related to review process with Line Manager/ Project Leader/Designee
  • Interacting with internal and external stakeholders for resolving issues
  • Attending and/ or presenting at client/cross functional meetings along with other stakeholders
  • Working as Subject Matter Experts (SMEs)
  • Assisting the Project Lead/Functional Lead for audits and inspections
  • Provides inputs for process improvements
  • Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process
  • Function as pharmacovigilance representative/safety scientist
  • Attend/support Bid defense meetings
  • Actively mentoring Patient Safety Physicians to develop their skills and expertise
  • Perform medical review of cases, including complex and challenging cases requiring expert judgment, covering clinical trial, literature, and combination product (drug-device) cases according to client/Parexel Standard Operating Procedures and liaising with the client, as required
  • Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
  • Review appropriateness of medical content in narrative for medical coherence
  • Assessing seriousness, listedness / expectedness of reported events
  • Providing medical inputs to case processing team
  • Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
  • Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative
  • Identify and resolve case issues, coordinate with client therapeutic/legal team
  • Provide guidance to junior physicians on case assessment methodologies

Requirements

  • MBBS or MD from a recognized medical school
  • 2+ years of experience in ICSR medical review
  • Good understanding of medical terminology
  • Experience in pharmacovigilance, drug safety, or clinical practice
  • Basic clinical training (internship/residency completed)

Nice to have

Experience in pharmacovigilance and medical monitoring (desirable)

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