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Safety Medical Writer

Fidelity Health Service
Fidelity Health Service
2-3 years
Not Disclosed
10 Feb. 4, 2025
Job Description
Job Type: Full Time Education: M. Pharm / B. Pharm / BAMS / BHMS / BDS (Health care professional) 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

Safety Medical Writer

Location: Mumbai
Qualification: M. Pharm / B. Pharm / BAMS / BHMS / BDS (Healthcare Professional)
Experience:

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

Job Responsibilities:

  • Preparation and quality review of various types of Aggregate Reports (AR) including PSUR, PBRER, Annual Safety Report, PADER, RMP, etc.
  • Strategizing for submission of ARs.
  • Arrange kick-off meetings with clients and relevant stakeholders (ICSR team, etc.).
  • Generate line listings and summary tabulations, referring to the processed ICSR for ARs and XML from a global safety database.
  • Identify and resolve issues.
  • Provide support for other departmental activities.