PV Assistant (Contract)
中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd.
- 公司规模:500-1000人
- 公司性质:合资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-10-23
- 工作地点:上海
- 招聘人数:1人
- 工作经验:无需经验
- 学历要求:本科
- 职位月薪:6-8千/月
- 职位类别:其他
职位描述
- open to fresh graduates
1. to support team logistic arragnement
2. to monitor the hotline and follow-up of missing message from RevCare program Responsibilities:
? Risk management plans
? Provision of safety information
? Implementation of PV Audit and Inspection Readiness
? Planning, processing and reporting of Aggregate Reports to HA and EC (as required)
? Maintenance of PV Awareness and Training
? Implementation of Pharmacovigilance Agreements
? Collection, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases
? Submission of single cases to local Health Agencies(HA) and Ethics Committees (as required)
? Local Market Safety Data Quality
Requirements:
? Ability to deliver quality work using strong organizational, facilitation and interpersonal skills in a cross-functional teams locally. Understands relationships within GPVE & externally.
? Develops a good understanding of the BMS organization, in particular the Global and Regional Safety groups and relevant local departments e.g. Regulatory and Clinical Teams and how these teams interact.
? Possess good interpersonal, verbal, and written communication skills. Able to learn the skills required to research, compile and provide safety information in a clear concise manner to the local team.
? University degree (preferably life science) or nursing qualification.
? Prefer to have some experience of working in a medical environment or a reasoned desire to gain experience in PV.
? Ability to develop a good understanding of local, regional and any other relevant legislation with regard to PV (e.g. ICH, CIOMS), as well as BMS corporate and local systems (e.g. Global Safety Database) and procedures, in order to fulfil regulatory requirements for Pharmacovigilance.
? Develops an awareness of the safety profile and any emerging PV issues with BMS products (marketed or investigational) in the local affiliate.
? Develops the ability to review safety information with attention to detail and accuracy in verification of source data and related safety documentation/records. Able to prioritize multiple tasks to meet deadlines, effectively solve PV issues and utilizing effective problem-solving approaches with guidance from supervisor. Ability to comply with relevant internal and external processes/guidelines/regulations.
职能类别:其他
公司介绍
百时美施贵宝是一家以“研发并提供创新药物,帮助患者战胜严重疾病”为使命的全球性生物制药公司。
2019年11月20日,百时美施贵宝成功完成了对新基的收购,将双方在领先的科学、创新的药物和优秀的人才等方面的优势合二为一,打造全球领先的生物制药企业。公司在肿瘤、血液、免疫和心血管疾病等领域处于世界前列,并具有丰富的,且具有行业前景的产品管线。
如今,中国已是百时美施贵宝公司全球重要的研发、生产、营销和创新中心之一。我们致力于满足中国未被满足的迫切的重大疾病需求,引领行业发展,开展多元合作,以帮助中国患者战胜严重疾病。
2019年11月20日,百时美施贵宝成功完成了对新基的收购,将双方在领先的科学、创新的药物和优秀的人才等方面的优势合二为一,打造全球领先的生物制药企业。公司在肿瘤、血液、免疫和心血管疾病等领域处于世界前列,并具有丰富的,且具有行业前景的产品管线。
如今,中国已是百时美施贵宝公司全球重要的研发、生产、营销和创新中心之一。我们致力于满足中国未被满足的迫切的重大疾病需求,引领行业发展,开展多元合作,以帮助中国患者战胜严重疾病。
联系方式
- 公司地址:地址:span南京