长沙招聘

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 Health Authority (HA) according to the Chinese regulation within the required timeframe;

To transmit all reports in English to the GPS 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 upon request by the HA;

Routine interaction with HA, monthly handling feedback cases

Routine case handling; spontaneous cases, literature cases

Hotline handling: pick up 24hrs hotline and hotline case intake

Monthly foreign cases line listings submitted online

To support BQ PV activities related, such as

Regular & ad-hoc safety committee meeting with stakeholders, material preparation.

Safety data provided as request

Safety analysis report preparation

Studies Activities

Working with clinical operation team for SAE reconciliation plan, and perform reconciliation if appropriate

 

PSURs

Understand China PSUR guidelines

Communicate with GPS safety writing team to draft PSUR following China guidelines

To collect and maintain product registration information and commercial data to be used for PSUR

Prepare the PSUR calendar every year and communicate with GPS medical safety writing team

To submit individual PSUR to HA

Communicate with HA officer to obtain approval of PSUR

 

Interaction with internal key stakeholders

Internal interaction with manufacturing plant acting as a PV representative for each of the manufacturing plant

Internal interaction with QA/RA/MA/CO for investigation of product safety related issues

External interaction with HA to ensure successful implementation of China PV regulation

Safety Committee Meeting

Work with BQ plant and ADR center

 

PV system process

Understand China PV regulation and Baxter China business

Work with PV manager to improve PV process / system

Support business projects via ensuring proper PV process are followed

 

AE reports- Case investigation

Draft death case investigation report

Draft group AE investigation report

Draft case analysis report as appropriate

Perform safety surveillance activities for potential safety signals (e.g. similar AEs reported in a cluster or multiple cases for one batch) and escalate as per procedures

Communicate effectively any safety signals observed to the appropriate management team

 

Support the label update and license renewal

Review safety section of the label

Draft safety summary for license renewal

 

Others:

Self-training: TCU, We Comply, external training, etc.

Team meetings and meeting arrangements

Monthly metrics update

Fax, group mailbox, post, etc. daily checking

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.