Local Drug Safety Associate

我們能夠提供：我們的好奇心來自多元的背景、觀點和生活經歷。我們接納並包容多元，並相信它能推動卓越和創新，強化我們在科技領域的領先能力。我們致力於為所有人創造機會，讓他們按照自己的步調發展和成長。加入我們，建立充滿包容和歸屬感的文化，影響數百萬人，並賦予每個人機會，施展出自己的超能力，進而推動人類進步！

立即申請，成為我們團隊的一員！

Your Role

1. Individual Case Safety Reports (ICSR) handling and reporting to local Health Authorities (HA) and Ethics Committees (EC) a) Handle local safety source information, including collection, registration, translation from local language into English, quality check and transmission to GPS as applicable in a timely manner b) Seek comprehensive initial and follow-up information on ICSRs from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner f) Timely submission of expedited ICSRs to concerned local health authorities g) Support e-reporting in countries where e-reporting is available h) Timely submission of expedited cases to concerned local/central EC/IRBs when described in Safety Management Plan 
2. Perform reconciliation, quality monitoring and spot check of safety information (e.g. ICSRs from spontaneous, solicited, study, complaint and PDCS sources) with the relevant functions
3. Local documentation and record retention in accordance with local legislation and company standards
4. Perform PV training activities on relevant safety-related matters for local functions (i.e. Medical Affairs, Regulatory Affairs, Clinical departments, Commercial departments and third parties, as necessary)
5. Perform required activities for obtaining PDCS approval (such as review and provide input to safety section of study/project documents, certification of programs, AE reconciliation, providing updates)
6. Submit pSUSAR (post-study Suspected Unexpected Serious Adverse Reaction) report and other specific safety reports according to country requirements
7. Support the preparation of Local Risk Management Plan (RMP) for local submission according to country requirements
8. Support the review process of Safety Data Exchange agreement (SDEA)s and local PV clauses in applicable contracts, in accordance with GPS procedures and local requirements
9. Handling IT & Systems
10. Contribute to local/global PV related audits or HA inspections as requested
11. PV Intelligence : monitor local PV regulations in the country, inform GPS on any changes with impact to distribution rules or other PV activities
12. Support Local PV System: ensure up to date and deep awareness and understanding of Local PV system as described in local/regional PV File (LPVF)
13. Support close collaboration with GPS/Regulatory Affairs/Medical Affairs/Clinical Development/Quality Assurance on the preparation of appropriate response documents to HA. 
14. Who You Are *需有自然人憑證 ( Taiwan Citizen digital certificate required)  1. Organizational skills, ability to prioritize tasks and rapidly adapt to changing priorities 2. Ability to comply with timelines and instructions 3. Ability to manage multiple situations/issues under time pressure 4. Ability to work independently 5. Good understanding of drug development and life-cycle management 6. Good knowledge PV regulations 7. Good problem solving and decision-making ability 8. Strong communication skills 9. Strong team-working skills 10. Basic mentoring skills 11. Basic understanding of project management skills 12. Basic leadership skills 13. Ability to work in a multicultural environment 14. Effective presentation skills 15. Proficient in MS Office 16. Good understanding of relevant systems and tools 17. Embraces digitalization and introduce new ideas

Who You Are

*需有自然人憑證
1. Organizational skills, ability to prioritize tasks and rapidly adapt to changing priorities
2. Ability to comply with timelines and instructions
3. Ability to manage multiple situations/issues under time pressure
4. Ability to work independently
5. Good understanding of drug development and life-cycle management
6. Good knowledge PV regulations
7. Good problem solving and decision-making ability
8. Strong communication skills
9. Strong team-working skills
10. Basic mentoring skills
11. Basic understanding of project management skills
12. Basic leadership skills
13. Ability to work in a multicultural environment
14. Effective presentation skills
15. Proficient in MS Office
16. Good understanding of relevant systems and tools
17. Embraces digitalization and introduce new ideas

我們能夠提供：我們的好奇心來自多元的背景、觀點和生活經歷。我們接納並包容多元，並相信它能推動卓越和創新，強化我們在科技領域的領先能力。我們致力於為所有人創造機會，讓他們按照自己的步調發展和成長。加入我們，建立充滿包容和歸屬感的文化，影響數百萬人，並賦予每個人機會，施展出自己的超能力，進而推動人類進步！

立即申請，成為我們團隊的一員！