Han (Lucia) Yin

Currently, I am the technology enablement manager in the Global PV case management department, and I am the global lead backup on this role. I was involved in several system change projects which were triggered by regulation changes, such as MDCP reporting change to FDA, Chinese E2B reporting to NMPA. Responsible for liaising with the IT department to make sure all new/updated system changes will meet safety data management requirements. Responsible for coordinating business UAT testers to be involved in system testing activities. Responsible for monitoring E2B outbound submission. Lead a centralized monitoring team to oversee the ICSR transmission among safety systems, and monitor the submission compliance to agency and business partners. Be involved in several E2B implementation projects eg. local agencies, EMA, and other companies, responsible for DMC related topics. Responsible for the souce data team. The team is responsible for screening and index all the incoming adverse event reports. Initiate the process to transfer China's local case data entry intake to the global data management center, build and lead the DMC team on this process.

Design the process of SUSAR case translation and submission to NMPA per E2B R3 implementation requirement. Lead the translation and submission team for one year to standardize the quality assurance and compliance monitoring process. Finalized process documentation to be audit-readiness. Contributed to internal developed adverse event automation data entry tool project. Responsible for system develop lifecycle documents from business perspective. Responsible for liaising IT department on Argus feature improvement. Responsible manager of the resource management team, responsible for monitor daily workload distribution, oversee resource requirements, and design resource management strategy. Managed global workload arrangement and disaster recovery during the MSD cyberattack period. Responsible manager of quality review workflow, making sure the review workflow granted the quality of high priority adverse event reports and also deliver knowledge and experience to the new staff. Act as a global project lead to align on the quality assurance standard among three global locations in 2016, and successfully finished the project at the beginning of 2017.

Global expert of E2B transmission. AE report final reviewer, responsible for reviewing and making sure quality of high priority adverse event reports. Team lead, supervised total 12 new staffs and designed a new mentoring plan for new staffs. All members passed 6-month probation period with good performance. Workload lead, designed the workload distribution plan for the whole team.

Responsible for analyzing, triaging, and processing all adverse experience information received for investigational and marketed products according to standard operating procedures for further reporting to the FDA and/or other worldwide regulatory agencies by Global Safety. In addition, collaborates with staff within the organization as well as cross-functionally.

Participate in an epidemiology program Translate documents Designed and distribute questionnaire to health professional in four provinces

Degree project: A Retrospective Study on Animal Bites in Sweden in 2001-2009. This project is based on Swedish national health and welfare statistic, aim to illustrate the animal-bite situation in Sweden, identify the relation between animal-bite incidence and gender, age, and culture and geographic factors.

Degree project: Research on organoselenium compound Ethaselen (BBSKE), a novel anti-cancer drug. My work focused on the effect of Ethaselen (BBSKE) on hepatic metabolic activity of cytochrome P450. Skills covered: Animal experiments (rat), cell culture, PCR, UV/IR analysis. Publication: (2nd author): YIN Jin; YIN Han; REN Xiao-yuan; XU Jing; ZENG Hui-hui, Effect of ethaselen on the content and activity of liver CYP450 enzyme in H-22 tumor bearing mice, Chinese Journal of New Drugs, 2009. 18.