Safety & PV Specialist II – Japanese Language | Hyderabad, India
Location: Hyderabad, India
Job Type: Full-Time
Job ID: 25104313
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization driving clinical development, medical affairs, and commercial innovation. Our approach places the patient and customer at the center, enabling efficient and compliant delivery of therapies across clinical and post-marketing phases.
With 29,000 employees across 110 countries, Syneos Health fosters an environment of career development, inclusion, and continuous learning, allowing professionals to grow while making a meaningful impact on patient safety worldwide.
Role Overview
We are looking for a Safety & PV Specialist II with Japanese language proficiency to support pharmacovigilance case processing, safety database management, and regulatory reporting. This role is ideal for candidates with JLPT N3 certification (N2 preferred), strong Japanese reading and writing skills, and prior pharmacovigilance or life science experience.
You will ensure accurate, high-quality, and compliant reporting of Japanese safety cases, maintain database integrity, and support global and local safety requirements.
Key Responsibilities
Pharmacovigilance Case Management
Review and reconcile safety case data in Argus or other safety databases, ensuring alignment between English and Japanese source entries.
Prepare Japanese narratives for domestic and global regulatory reporting.
Handle Japan-specific safety cases, including data entry from source documents in compliance with Japanese regulations.
Triage ICSRs, evaluate completeness and accuracy, and ensure timely reporting of expedited cases.
Perform literature screening, MedDRA coding, and quality review of ICSRs.
Validate and submit xEVMPD product records, including coding of indication terms.
Identify and manage duplicate ICSRs and maintain documentation in the Trial Master File (TMF) or PV System Master File.
Regulatory Compliance & Quality Assurance
Maintain adherence to SOPs, Work Instructions (WIs), GCP, ICH, and GVP guidelines.
Participate in audits and ensure inspection readiness.
Apply safety reporting intelligence to maintain regulatory compliance for Japan-specific and global cases.
Collaboration & Communication
Work effectively with internal teams, sponsors, and cross-functional stakeholders.
Support process improvement initiatives and contribute to team efficiency and compliance.
Foster professional relationships while ensuring project timelines and deliverables are met.
Required Qualifications
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field. Non-life science backgrounds with relevant PV experience considered.
Experience & Skills:
JLPT N3 certification mandatory; N2 preferred.
Prior experience in pharmacovigilance, drug safety, or related life sciences is preferred.
Strong Japanese reading and writing skills, including medical terminology and advanced kanji comprehension.
Experience with safety database systems, ICSR processing, MedDRA coding, and PV reporting.
Understanding of clinical trial processes (Phases II–IV) and post-marketing safety requirements.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), TeamShare, Visio, and email.
Ability to work independently, prioritize tasks, and maintain high accuracy.
Excellent communication, interpersonal, and organizational skills.
Why Join Syneos Health
Work on global pharmacovigilance operations, supporting clinical and post-marketing safety programs.
Gain expertise in Japan-specific regulatory reporting and case processing.
Collaborate with cross-functional global teams and enhance your skills in safety databases, coding, and compliance.
Be part of a diverse, inclusive, and growth-oriented culture that values professional development.
Apply Now
Advance your career as a Safety & PV Specialist II – Japanese Language at Syneos Health, contributing to patient safety, regulatory compliance, and global pharmacovigilance excellence.
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