北京招聘

Essential Responsibilities
• Serving as PV Deputy and support China Local Pharmacovigilance (PV) daily works, including safety report collection (China ICSR, Overseas case line listing, China Heath Authority bulk cases etc.), report translation, timely exchange with Global PV team, CIOMS report management, timely submission to China Heath Authority (HA), follow-up activity management to ensure compliance with HA Guidelines, Global SOPs and Local SOPs
• Perform reconciliation of safety information tracking logs with Global PV Team to ensure compliance of submissions to CSU and global regulatory agencies
• Perform applicable quality checks (e.g. translation, AE form, submission).
• Ensuring archiving of safety data in accordance with HA requirement and GE SOPs
• Ensuring availability of current organization charts, job descriptions, Curriculum Vitae and training records for safety personnel in the Affiliate(s)
• Support Digital MA project management, including WeChat platform maintenance and AE cases recording
• Support communication with China HA, Global PV team, RA, QA, Sales and Training team etc.
• Support Regulatory Authority inspections or internal audit relating to Pharmacovigilance
• Support submission of periodic report (e.g. PSUR) and preparation of other PV-related documents requested by other function teams
Role Summary/Purpose
This role shall support the management and conduct of all local PV activities; ensuring that local PV activities are conducted in compliance with regulatory and internal company standards. As PV regulations are becoming more stringent in China, it should be noted that this position will readily to adapt regulation changes and support setting up processes and ensuring a functioning pharmacovigilance system in China is in place.
Qualifications/Requirements
• Bachelor degree or above, major in Medicine/Pharmacy/ Science or equivalent.
• Pharmaceutical/biotechnology industry experience in PV or data management, including clinical trial and post-marketing experience
• Familiar with China HA regulations and ICH guidelines pertaining to Adverse Event Reporting
• Fluency in spoken and written English
• Health Care Professional or equivalent experience preferred
• Experience and skill with medical writing preferred
• Computer literacy (e.g. Microsoft Office software) and experience with Drug Safety Databases (e.g. Argus)
• Shall be willing to submit to a background investigation, including for example, verification of past employment, criminal history, and educational background
Desired Characteristics
• High sense of responsibility and ownership
• Competent communication skills and able to communicate effectively in a matrix environment
• High integrity, sense of urgency, ability to recognize time sensitivity
• Ability to identify and solve routine problems independently
• Sound attention to detail
• Ability to multi-task
About Us
GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com

GE医疗集团提供革新性的医疗技术和服务，以满足需求，使全世界更多的人能以更可负担的成本获得更好的医疗服务。GE专注于世界至关重要的问题，以优秀人才和领先技术致力于应对行业重大挑战。GE医疗集团在医学成像、软件和信息技术、患者监护和诊断、药物研发、生物制药技术、卓越运营解决方案等多个领域，助力专业医务人员为患者提供优质的医疗服务。