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Drug Safety Associate Ii

Parexel
Parexel
2+ years
Not Disclosed
10 Oct. 8, 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 Title: Drug Safety Support Specialist

Company: Parexel

Overview: At Parexel, our shared goal is to improve global health. Every role contributes to the development of therapies that benefit patients. We work with empathy and a commitment to making a difference.

Key Accountabilities:

  • Drug Safety Support:
    • Assist in developing project-specific safety procedures and workflows.
    • Set up safety databases and develop data entry guidelines.
    • Triage incoming reports for completeness and validity.
    • Ensure electronic documentation and quality control of drug safety information.
    • Enter case reports into safety databases and manage queries.
    • Code data and write case narratives.
    • Maintain project-specific files and assist with various drug safety activities.
    • Inform management of potential project scope changes.
    • Support medical monitoring activities as needed.
    • Participate in client and investigator meetings.
    • Conduct literature searches and prepare for audits.
    • Delegate tasks to Drug Safety Assistants as appropriate.
    • Assist with expedited reporting procedures and regulatory registrations.
    • Submit safety reports to investigators and track submission cases.

Skills:

  • Strong analytical and problem-solving abilities.
  • Proficient in database and literature searches.
  • Excellent interpersonal, verbal, and written communication skills.
  • Strong organizational and prioritization capabilities.
  • Collaborative team player with a client-focused approach.
  • Experience with relevant computer applications.

Knowledge and Experience:

  • Minimum of 2 years of relevant experience in ICSR case processing.