上海招聘

医药学相关专业背景，一年以上医药领域工作经验，药物临床研究经验优先。会日语优先！

RESPONSIBILITIES

• Process clinical trial safety data by triaging initial and updated safety data, reviewing safety/CEVA data for inconsistencies, contacting sites with queries as needed, ensuring safety/CEVA data is corrected by site staff, ensuring translation of safety/CEVA data, entering applicable safety data into a serious adverse event (SAE) database when needed; writing narratives; coding terms, as appropriate; ensuring initial reports are sent to customers or marketing authorization holders within agreed timelines; updating narratives when updated information is received, as appropriate;
  liaising with customer/marketing authorization holders, executing case closure, reconciliation and preparation of events for archiving.
• Process post-marketing safety data by receiving SAE and adverse event (AE) reports from various sources; identifying SAEs and AEs from literature sources; identifying brand of suspect product following receipt of report; identifying reporting sources; and assessing reportability and expectedness of events.
• Process regulatory safety data by assessing SAEs and advising the department on SAEs that qualify as expedited regulatory reports; advising team members on timelines, procedures and format to adopt for reporting to regulatory authorities; advising team members on changes in SAE regulatory reporting requirements in different countries; reporting SAEs to regulatory authorities when appropriate; liaising with local Quintiles offices to facilitate expedited reporting;
  liaising with safety lead and systems manager for regulatory tracking requirements; and maintaining and updating regulatory safety database.
• Process Clinical Event Validation and Adjudication cases in one or more of the following processes: Endpoint Adjudication Committee coordination, core laboratory coordination, and/or DMC administration and Steering Committee administration Job duties in this area include endpoint process design, including development of endpoint-related training, work flows and process documents; identification of endpoints for adjudication; ensuring (in conjunction with team members) that all required materials in support of an endpoint are obtained from the patient chart and prepared for submission; entering CEVA data into a tracking database as appropriate; management of endpoint and adjudication data, including tracking and reconciliation with Clinical Data Management; preparation and submit endpoint dossiers for adjudication; informing senior team members of progress toward endpoint objectives and any potential rate-limiting
  factors; and ensuring that for each reported endpoint in the clinical database, there is a matching, final endpoint adjudication.
• Participate in the review of existing core operating procedures (COPs).
• Identify and record quality problems and bring them to the attention of a senior team member.
• Interact with Physician and/or Project Medical Officer as appropriate.
• Generate status reports as required.
• Lead project start-up, with supervision.
• Draft project instructions/guidelines for project and amend when appropriate.
• Attend/present at investigator/CRA meetings.
• Liaise with PM and/or members of project team (CRAs, Data Management).
• QC of safety data.
• Ensure alert letters are submitted on time.
  
  REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• General working knowledge medical terminology
• Basic knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• Good understanding of Core Operating Procedures (COPs)
• Strong organizational skills
• Good communication skills
• Ability to successfully handle many internal clients competing for attention, services and resources
• Strong computer skills using applicable word processing applications
• Demonstrated word processing and data entry skills
• Good attention to detail and accuracy
• Good interpersonal and organizational skills
• Ability to be flexible
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
  
  MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor's degree or educational equivalent in a scientific or health care discipline; or equivalent combination of education, training and experience

ABOUT THE COMPANY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY