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

Syneos Health
Syneos Health
0-2 years
Not Disclosed
Pune, India
2 May 11, 2026
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm/M.Sc.or equivalent in life sciences Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

 

 

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

Company: Syneos Health
Job Title: Safety & PV Specialist I (Japanese Language)
Location: Pune, 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 Pune. 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, safety data translation, regulatory-compliant reporting, case processing, 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 in the Argus safety database
  • Ensure consistency between English source data and Japanese entries
  • Translate safety information into accurate and regulatory-compliant Japanese
  • Prepare Japanese narratives for Japan-specific safety 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:
    • Completeness
    • Accuracy
    • Regulatory reportability
  • Enter and maintain safety data in pharmacovigilance databases
  • Maintain tracking records 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
  • Support quality review of safety cases and reports

Regulatory Compliance & Reporting

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

Educational Qualification

Candidates should possess:

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

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


Required Experience

Preferred Experience Areas

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 with Japanese Language Skills Can Apply

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