Syneos Health®, a global leader in biopharmaceutical services, is hiring a Safety & Pharmacovigilance (PV) Specialist II – Japanese Language for its India operations. This role is ideal for professionals with Japanese language proficiency (JLPT N3/N2) and experience or interest in pharmacovigilance, drug safety, and ICSR processing. The position is office-based and available in Gurugram, Hyderabad, and Pune.
If you are looking to build or advance a career in pharmacovigilance jobs in India, particularly in Japan-focused safety case processing, this opportunity with Syneos Health offers strong exposure to global regulatory standards and long-term career growth.
Job Overview
- Job Title: Safety & PV Specialist II (Japanese Language)
- Company: Syneos Health®
- Job ID: 25104313
- Employment Type: Full-time
- Work Mode: Office-based
- Locations: Gurugram, Hyderabad, Pune (India)
- Industry: Pharmacovigilance / Drug Safety / Clinical Research
Key Responsibilities
As a Safety & PV Specialist II, your core responsibilities will include:
- Review safety case data in Argus safety database, ensuring consistency between English source data and Japanese entries.
- Translate and write high-quality Japanese safety narratives for regulatory-compliant reporting.
- Handle Japan domestic safety cases, including data entry from Japanese source documents as per local reporting standards.
- Perform ICSR processing activities such as case triage, data entry, MedDRA coding, and narrative writing.
- Evaluate ICSRs for completeness, accuracy, and regulatory reportability.
- Prepare and submit expedited safety reports in compliance with global and Japan-specific regulations.
- Identify and manage duplicate ICSRs and follow up on safety queries.
- Perform literature screening and review for safety signals.
- Support xEVMPD submissions, SPOR/IDMP activities, and product dictionary maintenance.
- Conduct quality review of ICSRs and maintain safety tracking logs.
- Ensure compliance with ICH GCP, GVP, SOPs, WIs, and global safety regulations.
- Support audits and inspections as required.
Qualifications & Eligibility
Mandatory Requirements
- JLPT N3 certification (mandatory); JLPT N2 preferred.
- Strong ability to read and write Japanese, including advanced Kanji knowledge.
- Bachelor’s degree in Life Sciences or Non-Life Sciences with relevant experience.
Preferred Skills & Experience
- Prior experience in pharmacovigilance, drug safety, or ICSR processing.
- Knowledge of Argus or other safety database systems.
- Understanding of clinical trial phases II–IV and post-marketing safety requirements.
- Familiarity with MedDRA coding, xEVMPD, SPOR/IDMP activities.
- Good knowledge of ICH GCP, GVP, and global safety regulations.
- Proficiency in MS Word, Excel, PowerPoint, Outlook, and shared content systems.
Salary & Benefits
- Estimated Salary Range: ₹6,00,000 – ₹12,00,000 per annum (based on experience and language proficiency)
- Comprehensive total rewards program
- Strong focus on career development and progression
- Access to technical, therapeutic, and regulatory training
- Inclusive Total Self culture promoting diversity and work-life balance
- Opportunity to work on global pharmacovigilance projects, including Japan-focused safety operations
Why Join Syneos Health?
Syneos Health has worked with 94% of Novel FDA-approved drugs and 95% of EMA-authorized products in the last five years. With operations in over 110 countries, the organization provides unmatched exposure to global clinical development and pharmacovigilance practices.
Working at Syneos Health means being part of a team that values quality, compliance, innovation, and patient safety.
How to Apply
