Sr Assoc Drug Safety 大连

月薪： 10-20万/年

该公司所有职位
  • 3-4年经验
  • 本科
  • 招1人
  • 11-23 发布
  • 补充医疗保险
  • 五险一金
  • 交通补贴
  • 通讯补贴
  • 专业培训
  • 年终奖金
  • 弹性工作
  • 定期体检

职位描述

职位描述： Sr Assoc Drug Safety*Responsibilities/DutiesAssoc Drug Safety will Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to.o entry of safety data onto adverse event database(s) and tracking systemso review of adverse events for completeness, accuracy and appropriateness for expedited reportingo write patient narrativeso code adverse events accurately using MedDRAo determine expectedness/listedness against appropriate labelo identifies clinically significant information missing from initial reports and ensures its collectiono ensure case receives appropriate medical reviewo prepare follow-up correspondence consulting the medical staff accordingly.o ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelineso reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines? Support electronic submission of safety reports to Korea MFDS and act as point of contact for safety related question to MFDS? Maintain a strong understanding of Covance’s safety database conventions or client specific database conventions, as appropriate.? Begin participating in signal detection and trend and pattern recognition activities, as appropriate.? Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events? Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).? Work with Data Management or client on reconciliation of safety databases.? Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.? Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting.? Maintains a comprehensive understanding of Covance Safety’s Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.? Possess knowledge of other procedural documents, e.g., SOPs, etc. that impact Safety.? Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.? Build and maintain good PV&DSS relationships across functional units.? Demonstrate role-specific Competencies on a consistent basis.? Demonstrate company Values on a consistent basis.? Begin to develop a good knowledge of contract assumptions; identifying out of scope work.? Read and understand Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.? Begin participating in Covance project teams and client meetings as appropriate.? Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.? Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.? Assist in the co-ordination of endpoint committees, as required.? Any other duties as assigned by management.*Education/QualificationsDegree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.*Experience*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance. 职能类别： 生物工程/生物制药 临床研究员 关键字： PV Drug Safety 药物安全 covance

联系方式

大连软件园高新园区汇贤园5号楼

公司信息

Why Covance? At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world. We Offer Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us!

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