职位描述

招聘人数：1 人

职位职责： 实习天数：5 天 / 周

Major Responsibilities (Describe main activities)
1. Manage collection, processing, documentation, reporting and follow-up of all adverse events
(AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), Spontaneous Reports (SR), registries, commercial programs, etc.
2. Ensure accurate and consistent transcription, translations and data entry of all Serious
Adverse Events (SAE) from source documents onto safety systems (e.g. SINA, ARGUS, etc)
with emphasis on timeliness and quality.
3. Ensure recording and tracking of receipts, submissions and distributions of SAEs, SRs, Investigator Notifications (IN), Periodic Safety Report Updates (PSUR).
4. Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE,
SR, IN, PSUR, ASR) to Local Health Authority (LHA) and/or clinical operations.
5. Work with other local/global DS&E associates to ensure accurate evaluation of safety data.
6. Interact and exchange relevant safety information with Local Health Authority, other functional groups and third party contractor, if applicable.
7. Survey and monitor Chinese pharmacovigilance regulations and provide update to global
DS&E organization.
8. Set up, update and implement local procedures to ensure compliance with DS&E global procedures and Chinese requirements.
9. Input, review and approval of program proposals for language, content and establishment of
necessary controls on collection and reporting of adverse event information.
10. Assure reconciliation is performed with other departments (e.g. Medical Information, Quality Assurance, Customer Service Centre and third party contractor, if applicable) for potential AEs resulting from medical inquiries and quality related complaints.
11. Management and maintenance all relevant DS&E databases.
12. Ensure timely preparation and submission of KPI reports on AE reporting including
identification of root cause(s) for late reporting to Local Health Authority, development and implementation of corrective action(s) as needed.
13. Develop and update training materials for pharmacovigilance and ensure training of CPO associates on relevant DS&E procedures for AE reporting, including field force and third party
contractor, if applicable.
14. Ensure support for and close-out of audits, corrective action plan, investigation and Health
Authority inspections.
15. Ensure training and oversight of staff, as applicable.
16. Manage and maintain efficient DS&E filing and archive system.
17. Ensure RMP implementation in PVO and coordination of RMP activities in CPO.

Ideal Background
Education: A degree in medicine, pharmacy, health discipline or life sciences
Languages:Fluent in both written and spoken English
Good working knowledge of Chinese