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Drug Safety Specialist

2+ years
Not Disclosed
10 Oct. 21, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

About This Role

Job Description:

The Drug Safety Specialist will provide technical and process-related support for drug safety management, including clinical trials and post-marketing activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

Key responsibilities include:

  • Processing Individual Case Safety Reports (ICSRs) from various sources
  • Conducting literature searches and reviews
  • Signal detection and management
  • Tracking regulatory information
  • Performing regulatory submissions
  • Supporting the preparation of aggregate and other study reports
  • Managing medical and product dictionaries, as applicable

The Specialist will also ensure ICSR compliance and quality through:

  • Quality reviews of ICSRs
  • Metrics generation
  • Investigation of late cases, in line with international and local regulatory reporting requirements, as applicable.