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Syneos Health®, a global leader in biopharmaceutical solutions, is hiring a Safety & Pharmacovigilance Specialist I (Japanese Language) for its India operations. This is an excellent opportunity for candidates with Japanese language proficiency (JLPT N3/N2) and pharmacovigilance or drug safety experience to work on Japan-specific safety cases, ICSRs, and global PV compliance activities.
With locations across Gurugram, Hyderabad, and Pune, this full-time, office-based role offers strong career growth in pharmacovigilance jobs in India, especially for professionals targeting Japanese PV roles.
🔍 Job Overview
- Role: Safety & PV Specialist I (Japanese Language)
- Company: Syneos Health®
- Job Type: Full-time
- Work Model: Office-based
- Locations: Gurugram, Hyderabad, Pune (India)
- Job Requisition ID: 25104312
🧾 Key Responsibilities
- Review and process ICSRs in Argus Safety database, ensuring accuracy between English and Japanese source data
- Translate and write Japanese safety narratives for regulatory-compliant reporting
- Handle Japan domestic safety cases per local PMDA and GVP requirements
- Perform MedDRA coding, drug coding, duplicate checks, and narrative compilation
- Triage safety cases and evaluate data for completeness, accuracy, and reportability
- Support expedited reporting in compliance with global and Japan-specific regulations
- Conduct literature screening for safety signals
- Work on xEVMPD, SPOR/IDMP activities, and product dictionary maintenance
- Ensure proper filing in TMF and PSMF as per SOPs
- Participate in audits and inspections when required
Primary Focus: Reading and writing Japanese medical and safety content (minimal speaking required)
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🎓 Qualifications & Eligibility
Mandatory Requirements
- JLPT N3 certification (N2 preferred)
- Bachelor’s degree in Life Sciences or relevant discipline
- Knowledge of medical terminology and safety databases (Argus preferred)
Preferred Skills
- Prior experience in Pharmacovigilance / Drug Safety
- Understanding of ICH-GCP, GVP, PMDA, and global safety regulations
- Experience with clinical trials (Phase II–IV) or post-marketing safety
- Strong attention to detail and ability to meet strict timelines
- Proficiency in MS Word, Excel, PowerPoint, Outlook
💼 Why Join Syneos Health?
- Work with a company involved in 94% of novel FDA-approved drugs
- Exposure to global pharmacovigilance operations, including Japan PV
- Strong focus on career development, training, and internal mobility
- Inclusive “Total Self” culture supporting diversity and work-life balance
- Opportunity to work on high-impact global clinical and post-marketing programs
💰 Salary (Estimated)
- ₹6,00,000 – ₹10,00,000 per annum
(Based on market standards for Japanese PV roles in India; actual salary may vary)
📝 How to Apply
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