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Chief Medical Safety Officer

Chief Medical Safety Officer

beBeeMedicineMeerut, Uttar Pradesh, India
1 day ago
Job description

Job Title : Senior Medical Safety Advisor

Key Responsibilities Include :

  • Medical Expertise : Provide medical knowledge in evaluating safety data and determining the relevance of adverse event reports within the context of a product's safety profile.
  • Review and Clarify Adverse Events : Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
  • Coding Review : Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data

Main Responsibilities :

  • Consultant Role : Internal consultant to pharmacovigilance case processing teams on projects being supported
  • Safety Reviews : Medical safety review of protocol, Investigative Brochure, and / or Case Report Forms (CRFs)
  • Aggregate Reviews : Aggregate reviews of safety information including clinical data, post marketing, literature review and observational studies
  • Service Delivery : Service delivery from productivity, compliance and quality perspective within regulatory timelines
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    Safety Officer • Meerut, Uttar Pradesh, India

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