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Safety Medical Writer

2-4 years
Not Disclosed
10 Aug. 2, 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, 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

Position: Aggregate Report Specialist

Qualifications:

  • M. Pharm / B. Pharm / BAMS / BHMS / BDS (Health Care Professional)

Location: Mumbai

Experience:

  • 2 to 3 years of experience in drafting and reviewing PADER, PSUR, PBRER, and RMP.

Job Responsibilities:

  • Prepare and conduct quality reviews of various Aggregate Reports (ARs), including PSUR, PBRER, Annual Safety Report, PADER, and RMP.
  • Strategize for the submission of ARs.
  • Arrange and conduct kick-off meetings with clients and relevant stakeholders (e.g., ICSR team).
  • Generate line listings and summary tabulations from processed ICSRs and XMLs in a global safety database.
  • Identify and resolve issues related to ARs.
  • Provide support for other departmental activities.

How to Apply:

  • Share your CV at hr@fidelityhs.com.