Physician Medical Safety Specialist

5 days ago

Bengaluru, Karnataka, India beBeeMedicalReviewer Full time ₹ 13,51,897 - ₹ 16,22,273
Medical Reviewer Job Description:

As a medical reviewer, you will be responsible for the comprehensive review of individual case safety reports (ICSRs) and ensuring compliance with regulatory requirements.

  • Perform medical review of ICSRs for accuracy, medical relevance, and consistency with source documents and safety database entries, in alignment with client requirements.
  • Conduct second-level triaging of non-serious cases to identify potential serious adverse events (SAEs), as per client-specific conventions.

Key Responsibilities:

  • Review and validate suspect product coding, event selection, MedDRA coding, grouping/subsuming, and event ordering.
  • Confirm and correct event coding and classification, ranking of events, seriousness criteria, and listedness/expectedness.
  • Perform comprehensive medical evaluation of adverse event reports including serious/expedited cases and pregnancy-related reports.
  • Assess adverse events for seriousness, listedness, and causality, ensuring all medically relevant data from source documents is accurately reflected.
  • Review and enhance narratives in compliance with client conventions.
  • Provide or verify company pharmacovigilance (PV) comments as needed.
  • Initiate appropriate follow-up queries based on the clinical context of the case.
  • Identify and escalate potential safety signals or concerns in line with client procedures.
  • Ensure completeness and medical soundness of cases before providing final medical sign-off.
  • Participate in literature surveillance and aggregate report medical review, ensuring compliance with regulatory timelines and SOPs.
  • Track and document inconsistencies in data entry and provide feedback for continuous improvement.
  • Collaborate closely with cross-functional teams to maintain scientific accuracy, clarity, and regulatory compliance in all case documentation.
  • Stay updated with international pharmacovigilance regulations and follow all applicable SOPs, guidelines, and best practices.
Required Skills and Competencies:
  • Strong analytical and critical thinking abilities
  • High attention to detail and scientific accuracy
  • Sound medical judgment and decision-making in line with pharmacovigilance standards
  • Proficiency in medical terminology, disease pathology, pharmacology, and therapeutics
  • Ability to analyze and interpret adverse event data
  • Strong written and verbal communication skills
  • Good comprehension and the ability to summarize complex medical data
  • Team player with effective interpersonal and collaboration skills
  • Familiarity with pharmaceutical industry practices and drug development processes (preferred)

Qualifications: MBBS and MD degrees are required. You are expected to work from the office with hybrid options. Relocation to one of our offices in Bangalore, Hyderabad, Mumbai, Pune, or Delhi is mandatory.

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