职位描述
职位描述: General SummaryThe purpose of the position is to ensure medical device safety vigilance is compiled tocompany policies and local regulations and to provide value-added medical safetysupport to healthcare professionals and assist in building and maintaining customerrelationships through professional interactions.Responsibility? Request the oversea AE data from source companies,compiling data as requiredand submitted to Health Authorities in compliance with the company’s proceduresand the local regulations. Work with Medical Affairs personnel to guarantee thatall domestic Adverse Events are properly investigated and the reports aregenerated and submitted to the competent Health Authorities in compliance withthe company’s procedures and the local regulations.? Prepare the local annual AE summary in collaboration with Medical Safetyofficer and submit in compliance with company’s procedures and the localregulations.? Collect medical device safety vigilance information regarding either JJMC/JJMSproducts or competitor’s products, from public resource regularly, evaluate andshare it with commercial team.? Provide the product specific AE summary to support product renew process perrequest.? Be familiar with products portfolio and related AEs, must continuously update theproduct knowledge? Support new product launch and ensure all the safety information is included inthe training material Develop an understanding and competence of SOPs,ICH/GCP,as well as ethical standards.? Build up and maintain healthy relationships with internal customers and externalexperts.? Take on any other task as assigned by line-manager/medical affairs manager.? Other responsibilities defined in written procedures.Principle Relations ( inside &outside company)– Medical safety function in regional, global and source companies– MA&CR team in JJMS/JJMC, regional, global and source companies– RA and QA team in JJMS/JJMC, regional, global and source companies– JJMS/JJMC HCC, Legal, Finance team,– JJMS/JJMC Franchise Marketing/Sales/Training and ProfEd team,– Key opinion leaders and investigatorsPersonal requirements– At least bachelor degree of clinical medicine, pharmacology or life science– At least 2 years’ experience in practicing medicine or medical product develop– Industry experience in pharmaceutical vigilance /medical safety, clinicaloperation, or medical affairs would be preferred– Be able to communicate in English, both orally and in writing– Good presentation skill– Having good co-operation abilities and a positive character. 职能类别: 政府事务管理 药品注册 关键字: Medical Safety Specialist 医学事务员 医学安全