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Safety & Pv Specialist I (Japanese Language

Syneos Health
Syneos Health
0-2 years
Not Disclosed
Hyderabad
2 May 11, 2026
Job Description
Job Type: Full Time Education: Bachelor’s Degree (BS) or Master’s Degree (MS) in: Life Sciences Pharmacy Biotechnology Biomedical Sciences Chemistry Regulatory Affairs Or related scientific disciplines Skills: Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs

 

Safety & PV Specialist I (Japanese Language) – Pharmacovigilance & Drug Safety Operations

Company: Syneos Health
Job Title: Safety & PV Specialist I (Japanese Language)
Location: Hyderabad, India
Job ID: 25105524
Department: Clinical Solutions / Pharmacovigilance


About the Role

Syneos Health is hiring a Safety & PV Specialist I (Japanese Language) for its Pharmacovigilance and Drug Safety operations team in Hyderabad. This role is ideal for professionals with expertise in Japanese language translation, ICSR Case Processing, Drug Safety Operations, MedDRA Coding, and Regulatory Safety Reporting.

The selected candidate will support Japan-specific pharmacovigilance activities including Japanese narrative writing, translation of safety data, case processing, regulatory-compliant reporting, and pharmacovigilance database management.

This opportunity is suitable for candidates with strong Japanese language proficiency and interest or experience in Pharmacovigilance, Clinical Safety, and Healthcare Operations.


Key Responsibilities

Japanese Pharmacovigilance Activities

  • Review safety case information within the Argus safety database
  • Ensure consistency between English source information and Japanese entries
  • Translate safety data into accurate, high-quality Japanese for regulatory reporting
  • Prepare and write Japanese narratives for Japan-specific cases
  • Handle Japanese domestic safety cases and related data entry activities

ICSR Processing & Drug Safety Operations

  • Process Individual Case Safety Reports (ICSRs) according to SOPs and project-specific safety plans
  • Perform case triage and evaluate safety cases for:
    • Accuracy
    • Completeness
    • Regulatory reportability
  • Enter and maintain safety data in pharmacovigilance databases
  • Maintain tracking and documentation for assigned safety activities

Medical Coding & Safety Review

  • Perform:
    • MedDRA coding
    • Drug coding
    • Medical history coding
    • Concomitant medication coding
    • Test result coding
  • Conduct literature screening and safety review activities
  • Identify and manage duplicate ICSRs
  • Perform quality review of safety cases and reports

Regulatory Compliance & Reporting

  • Assist in generating expedited safety reports within regulatory timelines
  • Support xEVMPD validation and submission activities
  • Participate in SPOR / IDMP-related activities
  • Ensure compliance with:
    • ICH Guidelines
    • GCP
    • GVP
    • Global and Japan-specific pharmacovigilance regulations
  • Participate in audits and regulatory review activities

Documentation & Clinical Trial Support

  • Ensure required documents are submitted to:
    • Trial Master File (TMF)
    • Pharmacovigilance System Master File
  • Maintain understanding of:
    • Clinical trial safety requirements
    • Drug development lifecycle
    • Post-marketing pharmacovigilance standards

Educational Qualification

Candidates should possess:

  • Bachelor’s Degree in:
    • Life Sciences
    • Pharmacy
    • Healthcare
    • Related disciplines

OR non-life science backgrounds with relevant knowledge and skills.