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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: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding

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

Location: Pune, India
Company: Syneos Health
Job Type: Full-Time
Department: Pharmacovigilance / Drug Safety / Japanese Market Safety Operations
Experience Required: 0–3+ years (Pharmacovigilance experience preferred, freshers with required language skills may apply)
Language Requirement: JLPT N3 Mandatory | JLPT N2 Preferred
Job ID: 25105524


About the Company

Syneos Health is a globally respected clinical research organization (CRO) and biopharmaceutical solutions provider supporting pharmaceutical, biotechnology, and healthcare innovators throughout the drug development and commercialization journey. With expertise in pharmacovigilance, regulatory compliance, clinical operations, and global patient safety, the organization offers strong career growth opportunities for multilingual healthcare professionals.

This opportunity is ideal for candidates interested in Japanese pharmacovigilance, drug safety case processing, medical translation, regulatory safety reporting, Argus database operations, and international pharmacovigilance workflows.


Job Overview

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

The selected candidate will support Japan-focused pharmacovigilance operations involving Japanese safety case review, ICSR processing, Argus database handling, medical narrative writing, safety data translation, MedDRA coding, literature screening, and regulatory compliance activities.

This is an excellent opportunity for multilingual professionals seeking specialized careers in Japan-market pharmacovigilance operations within a global CRO environment.


Key Responsibilities

Japanese Safety Case Processing

  • Review safety case data in the Argus safety database, ensuring consistency between English source documents and Japanese entries.
  • Translate clinical and safety-related information into accurate, regulatory-compliant Japanese.
  • Process Japan domestic pharmacovigilance safety cases according to country-specific reporting requirements.
  • Perform data entry using Japanese source documentation while maintaining quality and compliance standards.

Japanese Medical Narrative Writing

  • Prepare detailed and accurate Japanese medical narratives for regulatory submissions.
  • Interpret clinical safety information using strong Japanese language proficiency, including advanced kanji comprehension.
  • Ensure high-quality medical communication aligned with pharmacovigilance requirements.

Pharmacovigilance Case Processing

  • Support Individual Case Safety Report (ICSR) processing from intake through closure.
  • Perform case triage, completeness review, validation, and regulatory reporting assessment.
  • Enter and maintain safety case information in validated safety databases.
  • Follow up on incomplete case details and support timely query resolution.

Medical Coding & Safety Data Management

  • Perform MedDRA coding for adverse events, indications, medical history, and safety-related terminology.
  • Code concomitant medications, treatment details, and clinical findings.
  • Support safety database maintenance and pharmacovigilance coding quality.
  • Identify duplicate safety cases and perform manual recoding where required.

Regulatory Compliance & Reporting

  • Support expedited safety reporting according to global regulatory timelines.
  • Assist with:
    • xEVMPD validation and submissions
    • SPOR / IDMP activities
    • TMF documentation
    • PSMF support
  • Ensure compliance with:
    • ICH GCP
    • GVP
    • Global pharmacovigilance regulations
    • Internal SOPs and Work Instructions

Literature Review & Quality Support

  • Conduct literature screening for pharmacovigilance safety monitoring.
  • Support ICSR quality review and documentation checks.
  • Participate in audits and compliance activities.
  • Maintain accurate pharmacovigilance tracking records.

Cross-Functional Collaboration

  • Work with internal pharmacovigilance teams, regulatory stakeholders, and project teams.
  • Support collaborative delivery of global drug safety operations.

Required Qualifications

Educational Qualification

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

Mandatory Language Requirement

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

Technical Requirements

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