The Department of Clinical Pharmacy, School of Pharmacy, Chongqing Medical University, Chongqing, China.
Chongqing Office, Beijing Captain Science Co., Ltd., Beijing, China.
BMC Health Serv Res. 2023 Feb 14;23(1):152. doi: 10.1186/s12913-023-09089-0.
Pharmacovigilance in China has experienced rapid development in the past 30 years. The implementation of Good Pharmacovigilance Practice in China since the end of 2021 heralds a new era of pharmacovigilance affairs, which puts forward higher requirements for the quantity and quality of pharmacovigilance personnel. This study aimed to preliminarily explore the current career situations of pharmacovigilance professionals working in China for pharmaceutical companies.
A questionnaire was adapted from research in the USA and Europe with the help of several pharmacovigilance experts. Snowball sampling was used to conduct an exploratory survey to obtain the frequency of basic demographic information, work status, and career expectations of pharmacovigilance professionals working for pharmaceutical companies.
The personnel engaged in pharmacovigilance work for pharmaceutical companies were mainly medical or pharmaceutical undergraduates within 3 years of graduation. Their work intensity and pressure were relatively high. The training provided by their universities and enterprises could not well meet their needs to improve their job competence. Although they were optimistic about pharmacovigilance and will not change their career, most of them were planning to change their employers.
There was a gap between the demand and supply of pharmacovigilance personnel. Relevant regulatory authorities and industry associations should guide higher education institutions to collaborate with pharmacovigilance specialists to strengthen pharmacovigilance education for medical or pharmaceutical students, on the basis of which pharmacovigilance certification courses and continuing education courses can be developed. Meanwhile, pharmaceutical enterprises should consider reasonably adjusting work intensity and income to avoid a high turnover rate.
中国的药物警戒在过去 30 年中经历了快速发展。自 2021 年底以来，中国实施的《药物警戒质量管理规范》标志着药物警戒事务的新纪元，这对药物警戒人员的数量和质量提出了更高的要求。本研究旨在初步探讨目前在中国从事制药公司药物警戒工作的专业人员的职业现状。
在几位药物警戒专家的帮助下，对来自美国和欧洲的研究进行了问卷改编。采用滚雪球抽样法进行探索性调查，以获得制药公司药物警戒专业人员的基本人口统计学信息、工作状况和职业期望的频率。
从事制药公司药物警戒工作的人员主要是医学或药学本科毕业生，毕业时间在 3 年内。他们的工作强度和压力相对较高。他们所在大学和企业提供的培训并不能很好地满足他们提高工作能力的需求。尽管他们对药物警戒持乐观态度，并且不会改变自己的职业，但大多数人都计划更换雇主。
药物警戒人员的需求和供应之间存在差距。相关监管部门和行业协会应指导高等教育机构与药物警戒专家合作，在加强医学或药学学生药物警戒教育的基础上，开发药物警戒认证课程和继续教育课程。同时，制药企业应考虑合理调整工作强度和收入，以避免高离职率。
