Safety & PV Specialist II – Japanese Language | Pune, India
Location: Pune, India
Job Type: Full-Time
Job ID: 25104313
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization that accelerates clinical development by delivering innovative solutions in pharmacovigilance, medical affairs, and commercial strategies. With 29,000 employees across 110 countries, we bring patients and clients to the center of everything we do, driving efficiency, compliance, and innovation in clinical and post-marketing safety programs.
Our culture emphasizes career development, mentorship, inclusion, and continuous learning, providing opportunities to contribute to life-changing therapies while developing professionally.
Role Overview
We are seeking a Safety & PV Specialist II with Japanese language proficiency to manage pharmacovigilance case processing, database management, and Japanese regulatory reporting. This role is ideal for candidates with JLPT N3 certification (N2 preferred), strong Japanese reading and writing skills, and experience in pharmacovigilance or life sciences.
The successful candidate will work with global safety databases, review source documents in Japanese, and ensure accurate, high-quality, and regulatory-compliant case narratives.
Key Responsibilities
Pharmacovigilance & Case Management
Review safety case data in Argus or similar safety databases, ensuring consistency between English and Japanese entries.
Prepare Japanese narratives for domestic and global regulatory reporting.
Process Japan-specific cases, including data entry from source documents, in compliance with local regulatory requirements.
Triage ICSRs, evaluate completeness and accuracy, and ensure timely and accurate 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 ensure proper documentation in 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, inspections, and other quality-related activities as required.
Apply safety reporting intelligence to ensure compliance with global and Japan-specific regulations.
Collaboration & Communication
Work effectively with internal teams, sponsors, and cross-functional stakeholders.
Foster professional relationships while supporting regulatory compliance and timely project completion.
Provide input for process improvement initiatives within the Safety & PV function.
Required Qualifications & Experience
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 required; N2 preferred.
Prior experience in pharmacovigilance or drug safety preferred.
Strong Japanese reading and writing skills, including medical terminology and 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 tools.
Ability to work independently and as part of a team, prioritize tasks, and maintain high accuracy.
Excellent communication, interpersonal, and organizational skills.
Why Join Syneos Health
Contribute to global pharmacovigilance operations supporting clinical and post-marketing safety programs.
Gain exposure to Japan-specific regulatory reporting and case processing.
Collaborate with cross-functional global teams and develop expertise in safety databases and regulatory compliance.
Work in a culture that values diversity, inclusion, and professional growth.
About Syneos Health
In the past five years, Syneos Health has contributed to 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and managed 200+ clinical studies across 73,000 sites involving 675,000+ patients. We empower professionals to ensure safety, compliance, and quality while delivering transformative therapies globally.
Apply Now
Advance your career as Safety & PV Specialist II – Japanese Language and join a leading global pharmacovigilance and safety team, making a tangible impact on patient safety and regulatory compliance.
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