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Pharmacovigilance Specialist/ Iqvia Services

1+ years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Description

Position Title: Safety Information Management Specialist

Job Overview
This position involves managing safety information for clinical trials and post-marketing activities related to pharmaceuticals and medical devices. Specific responsibilities may vary depending on the project being recruited for.

Candidates with experience in post-marketing case processing in Japan are highly preferred.


Key Responsibilities

Individual Contributor (Specialist-Level):

  • Safety Information Management:
    • Receive, triage, assign case numbers, input data into databases, perform initial evaluation of PMDA reporting requirements, and conduct QC.
    • Create case narratives (in Japanese and English), draft reports to PMDA, and perform QC.
    • Develop follow-up queries for necessary safety evaluation information.
    • Identify individual case reports and safety measures from domestic and international literature and overseas measures information.
    • Input and QC data based on evaluations of domestic and international literature and overseas measures, and prepare and QC reports for submission to PMDA.
    • Submit various reports to PMDA, client partners, and clinical trial sites.
    • Conduct case aggregation review, signal detection, and evaluation.
    • Draft, QC, and submit periodic safety reports, infectious disease periodic reports, periodic reports on unknown non-serious adverse events, and annual reports for clinical trials.
    • Prepare and QC line listings for clinical trial sites.
    • Escalate and coordinate with clients.
    • Perform other related tasks as required.

Workflow Lead (Sub-Lead Level):

  • Manage the progress, quality, and productivity of daily operations for the above tasks.
  • Provide training, handle escalations, and offer support to the team as needed.

Work Location

  • Flexible Work Style: Primarily work from home.
  • Occasional office attendance required (Shinagawa HQ or Shin-Osaka).

Qualifications

Required:

  • At least 1 year of experience in safety information case processing (receiving, triaging, assigning case numbers, content verification, database input/QC).
    (Experience limited to receiving and case number assignment is also welcome).
  • Business-level proficiency in Japanese.
  • Educational background from a technical college, junior college, or specialized school.
  • Ability to build strong relationships with cross-functional teams and colleagues.

Preferred:

  • Over 3 years of experience in pharmacovigilance, including at least 1 year of case input and data QC.
  • Experience translating case information from Japanese to English.
  • Demonstrated leadership experience in safety information management (e.g., training new staff, SOP review, system updates, progress/quality management).
  • Ability to prioritize tasks and manage deadlines while working on multiple projects.
  • Strong relationship-building skills with clients.
  • TOEIC score of 600 or equivalent English proficiency.
  • Educational background in healthcare-related fields (e.g., medicine, pharmacy, clinical laboratory, nursing).

About IQVIA
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Learn more at IQVIA Careers.