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Clinical Qa Auditor - Ba/Be

2-6 years
Preffered by Company
5 Aug. 7, 2024
Job Description
Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D 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: Clinical QA Auditor - BA/BE

Location: Hyderabad

Experience Required: 2 to 6 years

Employment Type: Full Time

Qualification:

  • B.Pharm
  • M.Pharm
  • M.Sc

Roles and Responsibilities:

  • Study Audits: Plan and conduct BA/BE study audits (in-process and retrospective) in compliance with the protocol, SOPs, and applicable GxP standards and regulations.
  • Document Review: Review draft protocols, study ICFs, and study CRFs in line with applicable GxP standards and regulations.
  • Clinical Study Reports: Review eCTD and clinical study reports.
  • Timely Feedback: Provide document review comments in a timely manner.
  • Audit Reporting: Issue audit reports to the auditee, review and assess the audit responses/CAPA, and ensure the closure of the audit report in a timely manner.