Patient Safety Associate 药物警戒

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive drug development services. It partners with pharmaceutical and biotechnology companies to facilitate clinical trials and streamline the drug approval process. With a focus Ｏn innovation and quality, Fortrea leverages advanced technologies and a dedicated team of experts to deliver tailored solutions that enhance the efficiency and effectiveness of clinical research. The company is committed to improving patient outcomes and advancing healthcare through its work in various therapeutic areas. （https://www.fortrea.com/） Job Summary Patient Safety Associate is mainly responsible for safety report management and other activities assigned. This role should understand company’s code of conducts & compliances policies & China & global PV Regulations, and manage the daily Pharmacovigilance( PV) activity to align with these accordingly. • Maintain and receive safety report from all in-take channels; • Handle safety report from all sources ( clinical studies, spontaneous, literatures, NMPA, etc),including: - Data review, coding, translation and communication - Report to global Data entry site - Report to Health Authorities - Query answering - Tracking and archiving - Late case communication and complete CAPA • Support or perform any other task that management deems appropriate. Essential Requirement • Bachelor degree and above, major in medical, pharmacy or other relevant majors • Familiar with GCP • Good multiple works organisation skills and priorize assignments • Good verbal and writtern Russian and English bilingual proficiency • Proficient in common office software and office applications skills • Fresh or within 3 years relevant working experience