天津招聘

Summary:
Support PV Supervisor to deal with adverse events/serious adverse events processing, CIOMS forms collecting, monthly line listing submission, PSURs submission and related documents archiving in compliance with the national regulations for drugs and biologics and with the Baxter PV procedures.

Main Responsibilities:
? AE/SAE Processing
- To collect, process and follow up all local adverse events (AEs)/ serious adverse events (SAEs) from different sources (Healthcare professionals, sales and marketing personnel, patients, clinical trials, etc.);
- To report the AE/SAE to the HA according to the Chinese regulation within the required timeframe;
- To log in cases into the local tracking system and transmit all reports to the GPV organization within the required timeframe;
- To archive all source documentation in accordance with Quality Control;
- To file all Pharmacovigilance source documents and keep them available on request by the HA.

? Studies Activities
- To keep updated a table summarizing all clinical trials/ observational studies on-going in the countries, following information provided by the country for the local projects and information provided by GPV for others;
- To submit the Serious Adverse Events, unexpected events to HA according to the national regulations.

? CIOMS Form Collecting
- To maintain the Oracle AERS data base;
- To collect CIOMS form from GPV within the required timeframe.

? Line Listing Submission
- To collect monthly line listing from GPV;
- To reconsolidate the line listing between English version and Chinese version;
- To submit the approved Chinese version to HA

? PSURs
- To prepare the local annual AE summary, and send it to the HA according to the pharmacovigilance regulatory requirements;
- To submit individual PSURs released by the GPV to HA;

? Document Archiving
- To maintain the signed train record archiving;
- To maintain the hardcopy of package insert archiving;
- To archive the AE/SAE forms and receipt of GPV


Requirements:
1. Bachelor degree or above, major in clinical medicine or Pharmacy or healthy care professional related;
2. Knowledge of the relevant regulations, 1-2 years working experience in pharmaceutical company is preferred;
3. Good communication skills, ability to liaise with the different function;
4. Fluent in English both in oral & written;
5. Proactive, diligent, detail oriented and good in time management.

百特国际有限公司提供肾科与医院关键产品的广泛组合，包括居家透析、急重症透析和中心透析产品；无菌静脉输液；输注系统与设备；肠外营养；生物外科产品与麻醉；以及药房自动化、软件和服务。公司凭借全球布局，以及其产品与服务的必需性，在提升新兴与发达国家市场医疗可及性方面发挥至关重要的作用。百特在全球的五万名员工，秉承公司在医疗创新领域的深厚积淀，持续推动未来的医疗创新，更好地满足患者的医疗需求。

Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s 50,000 employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.