Make your mark for patients
We are looking for a Deputy Local Safety Officer to join us, based in Shanghai,China.
About the role
-
Support and back up the LSO of China to ensure that Pharmacovigilance systems,
operations and procedures are in place within the local organization for all territories
assigned to the Affiliate China 支持并协助本地安全官，确保所有分配在中国区域的药物警戒系统、
操作和程序都在本地组织中 -
The individual is responsible for the oversight of a compliant Pharmacovigilance (PV)
system with Cinkate to safeguard public health and maintain compliance with applicable
regulatory requirements. 负责监督欣凯的药物警戒系统合规性，以保障公众健康并保持并遵守适用的
监管要求。
What you’ll do
- Maintain a functional connection with the EEA Qualified Person for Pharmacovigilance (QPPV) e.g. participating in regular Local Safety Officer (LSO) meetings organized by corporate Patient Safety; 与EEA药物授权人（QPPV）保持职能联系，例如参加公司患者安全部组织的定期本地安全官员（LSO）会议；
- Ensure that the required local information for the Pharmacovigilance System Master File (PSMF) is made available to the EEA QPPV office, either directly or through local delegations (UCB colleagues or third parties); 确保药物警戒系统主文件（PSMF）所需的本地信息直接或通过本地代表（UCB同事或第三方）提供给EEA QPPV办公室；
- Implement and maintain a pharmacovigilance system for the UCB products authorized in the territory and ensure compliance with applicable regulatory and company requirements; 实施和维护区域内授权的UCB产品的药物警戒系统，确保符合适用的法规和公司要求；
- Work in close collaboration with corporate Patient Safety teams to ensure that local obligations are managed and compliance to local authorities is maintained; 与公司患者安全团队密切合作，确保当地义务得到管理，并遵守地方当局的规定；
- Provide input into global/local processes to secure compliance; 向全球/本地流程提供建议，以确保合规性；
- Maintain quality management system related to the pharmacovigilance, including management of Standard Operating Procedures (SOPs), Associated Instructions (AIs) and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed in order to ensure alignment with global SOPs; 维护与药物警戒相关的质量管理体系，包括标准操作程序（SOP）、相关说明（AIs）和文件（如表格、模板）的管理，以描述本地流程和要求，并根据需要进行定期差距分析，以确保符合全球SOP；
- Ensure timely management of deviations and risk mitigation by defining appropriate CAPAs and ongoing trend analysis as appropriate. 通过定义适当的CAPA和持续的趋势分析，确保及时管理偏差和风险缓解。
Interested? For this role we’re looking for the following education, experience and skills
- 4-5 years in Pharmacovigilance at minimum，Clinical Medicine Major
- Scientific background in Central Nervous System and/or immunology therapeutic areas helpful
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!
About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.