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无工作经验 -
招1人 -
11-09 发布
职位描述
职位描述： PURPOSEProvide medical experitise on pharmacovigilance services to all Quintiles divisions as requested. The Medical Safety Advisor participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.RESPONSIBILITIES？ Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary？ Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements？ Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported？ Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile？ Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data？ Represent safety and clinical data review findings during client meetings？ Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract？ Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.？ Act as Global Safety Physician or Assistant or Back-up on projects as assigned？ Attend project meetings, medical safety team meetings, and client meetings as requested？ Ensure coverage for all medical safety deliverables within regulatory or contracted timelines？ Provide medical escalation support for medical information projects？ Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects？ 24 hour medical support as required on assigned projects？ Maintain awareness of medical-safety-regulatory industry developmentsAll responsibilities are essential job functions unless noted as nonessential (N).REQUIRED KNOWLEDGE, SKILLS AND ABILITIES？ Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice？ Knowledge of clinical trials and pharmaceutical research process？ Ability to establish and meet priorities, deadlines, and objectives.？ Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility.？ Ability to establish and maintain effective working relationships with coworkers, managers and clients 职能类别： 生物工程/生物制药
联系方式
枫林路388号枫林国际大厦A座3楼
公司信息
QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you.
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