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Safety & Pv Specialist I (Japanese Language)

Syneos Health
Syneos Health
0-2 years
Not Disclosed
Remote, India, India
2 May 11, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: 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: Remote – India
Job ID: 25105524
Department: Clinical Solutions / Pharmacovigilance


About the Role

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

The selected candidate will support Japanese safety case handling activities, including translation of safety information, Japanese narrative writing, safety database review, MedDRA coding, and compliance with Japan-specific pharmacovigilance regulations.

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


Key Responsibilities

Japanese Pharmacovigilance Operations

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

ICSR Processing & Drug Safety Activities

  • 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 data into pharmacovigilance safety databases
  • Maintain safety tracking and documentation for assigned 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
  • Support quality review of safety cases and reports

Regulatory Compliance & Reporting

  • Assist in generation of 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 relevant documentation is submitted to:
    • Trial Master File (TMF)
    • Pharmacovigilance System Master File
  • Maintain understanding of:
    • Clinical trial safety requirements
    • Drug development processes
    • Post-marketing pharmacovigilance standards

Educational Qualification

Candidates should possess:

  • Bachelor’s Degree in:
    • Life Sciences
    • Pharmacy
    • Healthcare
    • Non-life science backgrounds with relevant skills and experience

Required Experience

Preferred Experience

Candidates with experience in the following areas will be preferred:

  • Pharmacovigilance
  • Drug Safety Operations
  • ICSR Case Processing
  • Japanese Safety Case Handling
  • Clinical Safety Operations

Freshers Can Apply

Candidates with strong Japanese language skills and healthcare interest may also be considered.