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Drug Safety Executive

Fidelity Health Service
Fidelity Health Service
1-3 years
Not Disclosed
10 Oct. 1, 2024
Job Description
Job Type: Remote 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

Job Posting: Drug Safety Executive

Company: Fidelity Health Services
Job Code: FHS/2024/DS/10
Designation: Drug Safety Executive
Qualification: B. Pharm / M. Pharm
Experience: 1-3 Years
Model: Work from Home

Job Description:

As a Drug Safety Executive, you will be responsible for the following tasks:

  • Perform duplicate checks, case management, and book-in activities using the Oracle Argus Safety Database.
  • Verify data accuracy in accordance with source documents and established procedures.
  • Conduct data entry and quality reviews of Individual Case Safety Reports (ICSRs) within Oracle Argus Safety.
  • Correct ICSR data while preparing special reports, including Health Hazard Assessment (HHA) reports, routine signal reviews, and post-process quality checks (PPQC), ensuring compliance with the FDA Adverse Event Reporting System (FAERS).
  • Handle and process scientific literature cases and other related reports.
  • Follow up on safety cases and generate action items in Argus.

Immediate joiners are preferred.

To Apply:

Please send your CV to hrrecruitment@fidelityhs.com and include the Job Code in the subject line of your email.

We look forward to your application!