行业:医药生物|医疗保健
职位:医药/生物工程
部门:
人数:若干
地区:北京
性质:全职
性别:不限
婚姻:不限
学历:本科
经验:不限
年龄:不限年龄
待遇:面议
500强 英语环境 全市班车 免费午餐
1. Primary Purpose of Job (Job Summary) 主要工作目标（岗位简介） Is operationally oriented in China AE collection, data processing in global safety database andsubmission to local HAs. Supports Safety Operation Specialist and (Associate, Senior) SafetyOperation Manager in any special tasks as assigned. Ensures all activities are performed incompliance with Roche SOPs and local regulatory requirements. 
2. Principle Roles & Responsibilities / Accountabilities 主要职责/责任(Major functions of the position) （职位的首要职能）​
Management of Individual Case Safety Report (ICSR) from all relevant sources in a proficient way.Ensures that collection, reporting and handling of safety information associated with Rocheproducts is performed according to global Roche and local regulatory requirements. ​Maintain links and liaisons with internal and external parties on Individual Case Safety Reports(ICSRs) and assigned tasks​Own ICSR process and quality and other assigned safety related process, ensure all activities areperformed in compliance with Roche SOPs and local regulatory requirements ​Support Safety Operation Specialist and (Associate, Senior) Safety Operation Manager in anysafety operational activities, including but not limited to           1) ​Submission of clinical trial SAE reports and SUSAR to local HA           2) Preparing, coordinating and submission of aggregate reports (PSUR/PBRER, foreign caseline listings, other HA mandated reports).                          Maintain the PSUR/PBRER submission schedule            3) Local PVA management and interaction with commercial partners           4) Providing safety supports for any technical complaints/counterfeit related issues           5) Query response and crisis/safety issue management according to global/local procedureand local regulations           6) CRM, local media and local literature monitoring           7) Oversight of MI-Atlas (QC, reconciliation, etc) for AE reporting           8) Supporting internal audits and regulatory inspections           9) Updating local training materials (internal and external) and ensure the training materialsare in line with global guidance and local HA                      requirement.           10) Ensure awareness and contribute (as applicable) to local safety label updates           11) Coordinating After Hours Coverage​ Mentor interns and new DSAs (where appropriate)3. Qualification and Experience 能力与经验​ ​Education/Qualifications 教育程度/所获资格证书 ​             Bachelors or Master Degree in health care related field (Health care professional, i.e., Clinicalmedicine, Pharmacist, Nurse.) or in bioscience. ​​Job Required Competencies 岗位所需胜任力          1)  Relevant working experience: Experience in drug safety or other pharmaceutical company ispreferable ​          2) Language: Working level of written and spoken English and Chinese          3) Computer skill: Computer literacy           4) Other skills and/or competence:               Medical knowledge of Roche products              Communication skills and teamwork