Safety & Pharmacovigilance Specialist Job in India at Syneos Health. Apply for Safety Specialist role with JLPT certification and PV experience preferred.
Introduction
For candidates with Japanese language expertise and an interest in pharmacovigilance, this is a unique and high-value opportunity. A global CRO is hiring Safety & PV Specialists who can work on Japanese safety cases and regulatory reporting. This role combines language skills with drug safety operations, making it ideal for candidates seeking a niche career path in pharmacovigilance.
Company Overview
Syneos Health is a globally established biopharmaceutical services organization that supports clinical development, medical affairs, and commercialization. The company collaborates with leading pharmaceutical and biotech firms worldwide, offering professionals exposure to global regulatory systems and advanced drug safety practices.
Job Overview
| Job Details | Information |
|---|---|
| Job Role | Safety & PV Specialist I (Japanese Language) |
| Company | Syneos Health |
| Location | Hyderabad / Gurugram / Pune |
| Experience | Freshers / Experienced |
| Qualification | Life Sciences / Any Graduate with Japanese |
| Employment Type | Full-Time (Office-Based) |
| Job ID | 25104313 |
Job Location & Employment Type
- Locations: Hyderabad, Gurugram, Pune
- Work Mode: Office-based
- Employment Type: Full-time
Open Positions / Department Details
- Department: Pharmacovigilance / Drug Safety
- Role Level: Entry to Mid-level
- Special Requirement: Japanese language proficiency
Key Roles & Responsibilities
As a Safety & PV Specialist with Japanese language expertise, your responsibilities will include:
- Reviewing safety cases in Argus database and ensuring data consistency
- Translating clinical and safety data from English to Japanese
- Writing Japanese case narratives for regulatory reporting
- Handling Japan-specific pharmacovigilance cases and documentation
- Processing Individual Case Safety Reports (ICSRs) as per SOPs
- Coding adverse events, medications, and medical history using MedDRA
- Entering and validating safety data in pharmacovigilance systems
- Identifying missing information and resolving queries
- Supporting expedited safety reporting within regulatory timelines
- Conducting literature screening and safety reviews
- Managing duplicate cases and ensuring data accuracy
- Supporting activities related to xEVMPD, SPOR, and IDMP
- Ensuring compliance with ICH-GCP, GVP, and global safety regulations
- Participating in audits and maintaining documentation
Eligibility Criteria
Education
- Bachelor’s degree in Life Sciences (preferred)
- Non-life science graduates with relevant skills can also apply
Experience
- Freshers and experienced candidates can apply
- Pharmacovigilance experience is an added advantage
Skills Required
Candidates must have:
- Japanese Language Proficiency:
- JLPT N3 (mandatory)
- JLPT N2 (preferred)
- Strong understanding of medical terminology
- Knowledge of pharmacovigilance and safety reporting
- Familiarity with safety databases (e.g., Argus)
- Knowledge of MedDRA coding
- Good analytical and attention-to-detail skills
- Strong written communication skills (especially in Japanese)
- Ability to work independently and in teams
- Proficiency in MS Office tools
Salary & Benefits
- Salary: As per company norms
- Opportunity to work on Japan-specific safety projects
- Exposure to global pharmacovigilance systems
- Career growth in niche drug safety roles
- Training and development programs
- Professional and collaborative work environment
Selection Process
The hiring process may include:
- Resume screening
- Japanese language assessment (reading/writing focus)
- Technical interview (PV concepts)
- HR discussion and final selection
How to Apply
Interested candidates should apply through the official careers portal of the company.
- Job ID: 25104313
- Apply online via company careers page
Important Dates
- Last Date: Not specified
Why Apply for This Pharma Job?
This role offers a rare combination of pharmacovigilance and Japanese language expertise, making it highly valuable in the CRO industry. By applying, you can:
- Work on international safety cases specific to Japan
- Build a niche career in multilingual pharmacovigilance
- Gain expertise in global regulatory reporting
- Increase your market value with language + technical skills
- Explore long-term opportunities in global CROs
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform. We are not affiliated with Syneos Health or its recruitment team. We only share job information for awareness purposes. Candidates are advised to verify details independently before applying.
Final Call-to-Action
If you have Japanese language certification and an interest in pharmacovigilance, this is a high-growth opportunity. Apply now and build a specialized career in global drug safety.
