【Primary responsibility】
The Case Management Specialist is to
 Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, client’s procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.
 The scope of support is primarily focused on assigned countries/territories. The role holder may be expected to support and ensure case management and related activities for other countries/territories within the ASPAC Region are carried out in a timely manner.

【Principal Responsibilities】
INBOUND & OUTBOUND ICSR CASE MANAGEMENT
 Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the client’s affiliates in assigned countries/territories.
 Enter relevant/required safety data into the Global Safety Database from spontaneous, clinical trials and other solicited sources for assigned countries/territories.
 Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.
 Data entry for complex cases (seek support from senior specialist as applicable)
 Performing follow-up for requesting additional information from multiple sources.
 Assist in the quality review of data captured in the Global Safety Database as applicable
 Verify and ensure translation of safety information, if applicable.
 Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.
 Enable mechanisms to support LSO oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner.


【COMPLIANCE MONITORING】
 Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable.

【AUDIT / INSPECTION PREPARATION AND SUPPORT】
 Support the LSO, in matters pertaining to audit or inspection preparation or conduct.

【OTHER ACTIVITIES】
Ensure and support other case management related activities such as:
o Local literature screening for ICSRs and potential safety signals (in consultation with LSO as needed), if applicable.
o Periodic reconciliation activities
o Support LSO in responding to ad hoc requests (e.g. regulatory authority requests) as required.
o Support critical project work
Collaborate with other case management-related personnel of clients, including Case Management Specialists/Coordinators,case processing SMEs in GMS, local medical safety medical team, in addressing internal and external ICSR related queries.

【其他條件】
- 大學生命科學, 醫藥相關科系畢業者/life, health or pharmaceutical sciences
- 具有醫藥或醫療器材管理（Intake oversight role）相關工作經驗者佳
- 英文能力佳（工作上會需要跨國合作溝通）
-積極, 具備溝通協調的能力,

【薪資條件】
- 面議，任職滿一年加發一個月(年薪13個月)
- 勞健保及勞退皆依政府規定

工作地點: 台北辧公室.(台北市中山區民生東路三段)

上班時間: 週一~週五9:00-18:00 .(週休二日)