Safety & PV Specialist I-Japanese

As a Safety & PV Specialist I at Syneos Health, based in the Pune Office, you will play a crucial role in ensuring the safety and pharmacovigilance of our products. Your primary responsibility will be to enter information into PVG quality and tracking systems for the receipt and tracking of ICSRs. Additionally, you will assist in the processing of ICSRs according to SOPs and project-specific safety plans. In this role, you will triage ICSRs, evaluate the data for completeness and accuracy, and ensure regulatory reportability. You will enter data into the safety database, code events, medical history, concomitant medications, and tests, and compile complete narrative summaries. Your attention to detail will be essential as you identify information to be queried and follow up until all queries are satisfactorily resolved. Moreover, you will be responsible for generating timely and accurate expedited reports in compliance with regulatory requirements. You will maintain safety tracking for assigned activities, perform literature screening and review for safety, drug coding, and MedDRA coding. Your role will also involve validation and submission of xEVMPD product records, management of duplicate ICSRs, activities related to SPOR/IDMP, quality review of ICSRs, and ensuring all relevant documents are submitted to the TMF and Pharmacovigilance System Master File. To excel in this position, you must maintain a thorough understanding and compliance with SOPs, global drug regulations, GCP, ICH guidelines, and project/program plans. Building constructive relationships with internal and external team members, participating in audits, and applying regulatory intelligence to safety reporting activities will be vital components of your role. Syneos Health is committed to developing its employees and providing a supportive and inclusive work environment where you can be your authentic self. Join us in our mission to accelerate customer success and make a meaningful impact on the lives of patients worldwide.,