Syneos Health Is Hiring A Safety & Pv Specialist I

📌 Join Our Team as a Safety & PV Specialist I (Japanese Language) at Syneos Health

Syneos Health, a leading fully integrated life sciences services organization, is seeking a dedicated Safety & PV Specialist I with proficiency in Japanese to join our dynamic Clinical Solutions team. Help accelerate customer success and make a meaningful impact in healthcare through innovative pharmacovigilance activities.

🌟 About Syneos Health

We partner with innovators across the drug development and commercialization continuum, navigating complexities and fostering progress. Our team members act with a drug development mindset, bringing deep expertise and a customer-centric approach.

Whether in a Functional Service Provider partnership or a full-service environment, you'll collaborate with passionate problem solvers committed to delivering results for those in need.

Discover why 25,000 colleagues love working here — focused on career development, inclusive culture, and making a real difference in healthcare. Our purpose, Driven to Deliver, inspires us to shape impactful solutions daily.

📝 Job Responsibilities

• Review Safety Data: Analyze safety case information in the Argus database, ensuring consistency between English source data and Japanese entries. Translate relevant data into high-quality, regulatory-compliant Japanese reports.
• Japanese Narratives: Prepare and write narratives tailored for Japan-specific safety cases as needed.
• Domestic Safety Cases: Handle Japanese safety cases, including data entry from source documents, adhering to Japan-specific reporting standards.
• Language Skills: Focus on reading and writing Japanese, including unstructured database fields with minimal speaking requirements, demonstrating strong language proficiency and medical comprehension.
• Pharmacovigilance Knowledge: Background or experience in drug safety, medical sciences, or pharmacovigilance is advantageous.
• Data Entry & Processing: Enter ICSRs into PVG systems, assist with processing safety reports, evaluate data for accuracy, and generate summaries.
• Safety Monitoring: Maintain safety tracking, conduct literature screening, and perform MedDRA coding and validation activities.
• Regulatory Submissions: Validate and submit xEVMPD product records, manage duplicate ICSRs, and ensure compliance with regulatory guidelines.
• Documentation & Compliance: Ensure all reports and documents are submitted per SOPs, maintaining adherence to GCP, ICH, GVP, and other regulations.
• Collaboration & Quality Assurance: Foster professional relationships, participate in audits, and perform quality reviews of ICSRs.

🎓 Qualifications

• Language Certification: Mandatory JLPT N3 certification; JLPT N2 preferred.
• Experience: PV or pharmacovigilance experience is preferred.
• Educational Background: Bachelor's degree in life sciences or related fields, with relevant experience.
• Technical Skills: Proficiency in safety database systems, medical terminology, and Microsoft Office Suite.
• Knowledge: Understanding of clinical trial processes (Phases II-IV), post-marketing safety, ICH GCP, GVP, and regulatory requirements.
• Skills: Excellent communication, organizational ability, attention to detail, and the capacity to work independently and within a team.

🚀 Join Us and Make a Difference

At Syneos Health, you will be part of a global team dedicated to shaping the future of healthcare. Bring your expertise, passion, and Japanese language skills to contribute to meaningful advancements in patient safety and pharmaceutical development.