Chinese Language Expert - Safety & PV Specialist I

As a Safety & Pharmacovigilance Specialist I at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients participating in clinical trials and post-marketing programs. Your responsibilities will include entering information into PVG quality and tracking systems, preparing project plans, processing ICSRs according to SOPs, and generating accurate reporting of expedited reports in compliance with regulatory requirements. You will be responsible for triaging ICSRs, evaluating data completeness and accuracy, entering data into safety databases, compiling narrative summaries, and assessing information to be queried. Additionally, you will participate in activities such as literature screening, drug coding, MedDRA coding, quality review of ICSRs, and validation and submission of xEVMPD product records. Collaboration and communication are key aspects of this role, as you will work closely with data management staff, project teams, and external stakeholders to ensure the timely and accurate reporting of safety data. Your role will also involve serving as a subject matter expert in SPVG, mentoring new hires, and participating in audits/inspections as required. To be successful in this role, you should have a Bachelor's Degree in life science, nursing, pharmacy, or a related field, along with knowledge of safety database systems, medical terminology, and clinical trial processes. Proficiency in Microsoft Office Suite, excellent communication skills, attention to detail, and the ability to work both independently and collaboratively are essential. Minimal travel may be required for this position. Syneos Health is committed to providing a supportive and inclusive work environment where employees can authentically be themselves and contribute to meaningful projects that impact lives globally. Join us in our mission to accelerate customer success and make a difference in the world of biopharmaceutical solutions.,