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Safety & Pharmacovigilance Specialist I

Syneos Health
Syneos Health
0-3 years
preferred by company
Pune, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs

Safety & Pharmacovigilance Specialist I (Japanese Language) – Japanese Pharmacovigilance Jobs in Pune | Drug Safety | Syneos Health

Location: Pune, India
Company: Syneos Health
Job Type: Full-Time
Department: Pharmacovigilance / Drug Safety / Japanese Safety Operations
Experience Required: 0–3+ years (Candidates with pharmacovigilance experience preferred)
Language Requirement: Mandatory Japanese Language Proficiency (JLPT N3 required, JLPT N2 preferred)
Job ID: 25105524


About the Company

Syneos Health is a globally recognized clinical research organization (CRO) and biopharmaceutical solutions company supporting pharmaceutical, biotechnology, and healthcare innovators across the complete drug development and commercialization lifecycle. With deep expertise in clinical research, pharmacovigilance, regulatory operations, and global patient safety, Syneos Health offers excellent career opportunities for multilingual healthcare professionals.

This opportunity is ideal for candidates seeking careers in Japanese pharmacovigilance, drug safety case processing, medical translation, ICSR handling, safety database operations, and global regulatory safety reporting.


Job Overview

Syneos Health is hiring a Safety & Pharmacovigilance Specialist I (Japanese Language) for its Pune office. This role is ideal for candidates with strong Japanese language proficiency and an interest or background in pharmacovigilance, drug safety, clinical research, or medical documentation.

The selected candidate will support Japanese safety case processing, pharmacovigilance case review, Japanese medical translation, Argus safety database operations, narrative writing, MedDRA coding, regulatory reporting, and compliance-driven global safety workflows.

This is an excellent opportunity for multilingual professionals seeking specialized careers in global pharmacovigilance with Japan market exposure.


Key Responsibilities

Japanese Pharmacovigilance Case Processing

  • Review safety case data within the Argus safety database to ensure consistency between English source documentation and Japanese case entries.
  • Translate safety-related clinical and medical information into accurate Japanese for regulatory-compliant reporting.
  • Process Japan domestic pharmacovigilance safety cases according to country-specific reporting requirements.
  • Enter Japanese source document data accurately into pharmacovigilance systems.

Japanese Medical Narrative Writing

  • Prepare and draft high-quality Japanese case narratives for regulatory submissions.
  • Interpret clinical safety information accurately using advanced Japanese language proficiency, including medical terminology and complex kanji comprehension.
  • Support regulatory documentation for Japan pharmacovigilance workflows.

ICSR Processing & Drug Safety Operations

  • Process Individual Case Safety Reports (ICSRs) in compliance with SOPs and project safety plans.
  • Perform case triage, validation, completeness review, and regulatory reporting assessment.
  • Enter and maintain safety data in validated pharmacovigilance databases.
  • Follow up on incomplete case information and support case closure.

Medical Coding & Safety Data Management

  • Perform MedDRA coding for adverse events, indications, medical history, and related safety terms.
  • Code concomitant medications, laboratory findings, and treatment-related information.
  • Support drug dictionary maintenance and coding accuracy.
  • Detect duplicate safety reports and perform manual recoding when required.

Regulatory Reporting & Compliance

  • Support expedited safety reporting aligned with global regulatory requirements.
  • Assist with:
    • xEVMPD validation and submissions
    • SPOR / IDMP activities
    • Trial Master File (TMF) documentation
    • Pharmacovigilance System Master File (PSMF) support
  • Ensure compliance with:
    • ICH GCP
    • GVP
    • Pharmacovigilance SOPs
    • Global drug safety regulations
    • Clinical trial safety standards

Literature Review & Quality Activities

  • Conduct literature screening and pharmacovigilance literature review.
  • Support ICSR quality review activities.
  • Participate in audits and safety compliance initiatives.
  • Maintain pharmacovigilance tracking and reporting documentation.

Cross-Functional Collaboration

  • Work with internal pharmacovigilance teams, regulatory stakeholders, and global project teams.
  • Maintain professional communication across multicultural project environments.

Required Qualifications

  • Bachelor’s degree in:
    • Life Sciences
    • Pharmacy
    • Biotechnology
    • Healthcare
    • Or non-life science backgrounds with relevant capabilities

Mandatory Language Requirement

  • JLPT N3 Certification (Mandatory)
  • JLPT N2 Certification (Preferred)

Technical Requirements

  • Knowledge of:
    • Safety database systems (Argus preferred)
    • Medical terminology
    • Pharmacovigilance workflows
    • Clinical trial processes (Phase II–IV)
    • Post-marketing safety requirements
    • ICH GCP / GVP regulations
  • Proficiency in:
    • Microsoft Word
    • Excel
    • PowerPoint
    • Outlook
    • Shared collaboration platforms