清远招聘

PRIMARY FUNCTION

• Be accountable for ensuring effective, high quality and efficient management of drug safety operations’ deliverables and strategic planning for functional needs, to ensure compliance with applicable global regulations and guidelines on Pharmacovigilance. 

MAJOR RESPONSIBILITIES, AND DUTIES

• Provide strategic planning, implementation, and management of Drug Safety Operations activities.
• Actively monitor the development and post-marketing safety requirements per ICH, China and other international regulations and guidelines and provide insights on the trends of safety requirements.
• Accountable for identification, development and implementation of pharmacovigilance (PV) process improvements, tools, systems and procedures to enable excellence and consistency in operations.
• Ensures implementation of standardized processes and procedures (SOP) for Drug Safety Operations activities to ensure PV compliance, including Adverse Event (AE) processing and aggregate reporting.
• Supervises operations personnel (direct reports, consultants) including mentoring and training.
• Establishes PV CRO oversight procedures and Key Performance Indicators (KPIs).
• Ensures that the PV Database supports the functional needs and provides oversight of systems and MedDRA updates in collaboration with the relevant PV CRO.
• Responsible for timeline management and ensuring global submission of aggregate safety reports and line listings such as DSURs and other aggregate safety reports (e.g.; PSURs/PBRERs) as required.
• Supports training of functional personnel and other line functions involved in AE collection or processing such as Medical Affairs, sales, medical information, etc.
• Supports training of functional personnel and other line functions involved in AE collection or processing such as Medical Affairs, sales, medical information, etc.
• Responsible for the creation, oversight and management of business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity
• Develops and implements an inspection readiness program with the contribution of other PV and non-PV stakeholders
• Ensures compliance-related investigations, and development and implementation of corrective actions for deviations from case processing procedures are performed accurately and on time.
• Participates in regulatory inspections and audits to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting requirements, including authoring of responses to findings relevant to functional area.
• Provides expert safety/pharmacovigilance guidance to clinical trial project teams and/or external partners to develop procedures and logistics for clinical trials.

 Qualifications

• Bachelor Degree in Medicine or Pharmacy/Master above preferred
• Fluent written and spoken English and Chinese
• Computer Skill: Computer literacy, knowledge with
• Medical PV knowledge and experience required
• Good knowledge of ICH, FDA and EMA PV regulatory requirement
• Good problem solving skills, communication skills and ability to learn new knowledge
• Good player to work both with a team as well as independently

和黄中国医药科技有限公司（简称“ 和黄医药 ”或“ Chi-Med ”）（纳斯达克 / 伦交所：HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。

和黄医药成立于2002年，为在纽约和伦敦两地上市的和黄中国医药科技有限公司（纳斯达克/伦交所： HCM）旗下专注于新药研发业务的子公司, 研发中心坐落在上海浦东张江高科技园区，海外临床开发及注册中心位于美国新泽西，具有完备的研发平台和GMP生产基地。管理团队成员均有在知名跨国医药和生物医药企业工作的经历，参与了多个全球新药研发；公司目前有500余位来自海内外，拥有丰富新药研发经验的科研人员，8大临床在研药物、 30多项临床试验在全球开展。

和黄医药是一家致力于创新药物研发的生物医药公司，专注于发现和开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。 自主研发的抗肿瘤新药呋喹替尼已于2018年9月获国家药品监督管理局批准上市，并于2019年11月获纳入国家医保药品目录。公司的其他候选药物，如索凡替尼、沃利替尼等，也已进入后期开发，有望在2020及2021年上市。