工作职责
1)Lead Product Safety Surveillance and Risk Management throughout product lifecycle;
带领产品全生命周期内的安全监测和风险管理:
2)Medical Review and Assessment for Safety Data
安全数据的医学审查和评估;
3)Plan and ensure timely submission of Aggregate Reports according to regulations.
按照法规要求制定汇总报告的计划并确保按时递交;
4)New Safety Information Communication;
新的安全性信息的沟通:
5)Perform contract review and maintain oversight to ensure Safety Reporting, Signal Detection and Periodic Reports obligations are defined and integrated in the agreement, e.g. Pharmacovigilance Agreements (PVAs) or Safety Data Exchange Agreements (SDEAs).
审核合同,并监督确保安全性报告、信号检测以及周期性报告的义务被清晰地定义并纳入,如药物警戒协议(PVA)或安全性数据交换协议(SDEA)。
6)Ensure PV audit and inspection readiness at all times from Medical Safety perspective.
从医学安全角度,确保随时准备好PV审计和检查。
7)People Management/Mentoring人员管理/辅导
8)其他药物安全相关的工作。
任职资格
1)Bachelor or higher education of clinical medicine/pharmacology/epidemiology/ or other relevant specialty. Clinical medicine is preferred.
临床医学/药学/流行病学/或其他相关专业,学士或者更高学历。优选临床医学专业。
2)At least 5-8 years’ experience on PV/medical/clinical in pharmaceuticals industry.
至少5-8年在医药行业中从事药物警戒/医药/临床相关工作的经验。
3)Familiar with PV related regulations and GCP, and can conduct related training and quality control;
熟悉药物警戒相关的法规,熟悉临床试验管理规范的知识,并能执行相关培训及质量控制;
4)Strong Leadership Skills, especially influencing senior management and key stakeholders to achieve strategic goals.
较强的领导力技能,特别是能够影响高级管理层和重要的利益相关方,从而达成战略目标的能力。