Safety & PV Specialist I (Japanese Language Expert)

As a Safety & PV Specialist I (Japanese Language Expert) at Syneos Health, your role will be crucial in ensuring the safety and well-being of patients involved in clinical trials and post-marketing programs. Here is a detailed overview of your responsibilities: - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. - Assist in processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans. - Triage ICSRs, evaluate data for completeness, accuracy, and regulatory report ability. - Enter data into safety database and code events, medical history, concomitant medications, and tests. - Compile complete narrative summaries and identify information to be queried. - Generate expedited reports in accordance with regulatory requirements and maintain safety tracking for assigned activities. - Perform literature screening and review for safety, drug coding, and maintenance of drug dictionary. - Validate and submit xEVMPD product records and manage duplicate ICSRs. - Quality review of ICSRs and ensure compliance with SOPs, regulations, and guidelines. - Foster constructive working relationships with project team members and participate in audits as required. - Apply safety reporting regulatory intelligence to all safety reporting activities. Qualifications: - No specific qualifications mentioned in the job description. About Syneos Health: Syneos Health is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. With a focus on customer and patient-centric approach, we strive to simplify work processes and deliver therapies efficiently. With a diverse workforce and commitment to employee development, we aim to create a work environment where everyone feels valued and supported. Discover more about Syneos Health at [http://www.syneoshealth.com](http://www.syneoshealth.com) Please note that the tasks and responsibilities outlined in this job description may not be exhaustive and additional duties may be assigned at the company's discretion. The company values equivalent experience, skills, and education, and will determine qualifications based on individual merit. Syneos Health is committed to compliance with relevant regulations and providing reasonable accommodations as needed.,