Regional Country Safety Specialist (Chinese Speaking)

Description Position at Premier Research Premier Research is looking for a Regional Country Safety Specialist (Chinese speaking) to join our Pharmacovigilance team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for BiotechSM. Join us and build your future here. What You'll Be Doing: Reviews, supports, and maintains the safety regulatory intelligence for assigned countries by reviewing local requirements on a periodic basis and cross-referencing with Premier's Regulatory Intelligence platform. Submits safety reports to regulatory authorities and ethics committees via registered portals or local regulatory systems (e.g., Eudravigilance/FAERs, etc.). Submits safety reports to sites as required in the protocol and the SMP. Maintains tracking of safety submissions either using a manual tracker or a safety document distribution platform. Performs QC of submission evidence against the tracker for manual submissions and in the safety portal for offline submissions at a level determined in the SMP. Supports the preparation of expedited and periodic safety report submission status updates and KPIs, as required, for Sponsor/Customer. Employees may be regionally based, if there is a local requirement and, in this capacity, will act as a local SME and will review the safety intelligence for their region. Files documents according to project-specific requirements (electronically or in hard copy as applicable) and submission evidence in the eTMF. Supports in the preparation of data for internal project review meetings and participates as required. Participates in audits and inspections as required/appropriate. Maintains a detailed understanding and stringent compliance with Standard Operating Procedures (SOPs), Working Guidance documents, global drug/biologic/device regulations, GCP/GVP guidance. What We Are Searching For: Undergraduate degree or its international equivalent in a clinical, science, or health-related field from an accredited institution or a licensed healthcare professional. 1-2 years of experience in Safety submissions related activities. Fluency in English and Chinese languages. Working understanding in Clinical Trial PV Submissions for the allocated region. Working experience in registering for submission accounts in different countries, completing submissions manually or through any System. Good understanding of the clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP, and regulations related to Clinical Safety and Pharmacovigilance. Good understanding of regulatory requirements. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), (or other management/shared content/workspace) and internet. Ability to work independently and in a team environment. Good communication and interpersonal skills, both written and spoken. Good organizational skills with proven ability to prioritize and work on multiple tasks and projects. Detail-oriented with a high degree of accuracy and ability to meet deadlines. Why Choose Premier Research? Premier Research is more than a company - it's a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. Our cultural anchors - Caring & Empathy, Empowerment, Aspiration, One Team - mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful. Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve. We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others. #LI-TB1 #J-18808-Ljbffr