长沙招聘

Represents and is responsible for the local Pharmacovigilance activities of products (drugs) manufactured / imported by below entities.

                          Baxter Healthcare Trading (shanghai) Co., Ltd.

                          Baxter Healthcare (Shanghai) Co., Ltd.

                          Baxter Healthcare (Guangzhou) Co., Ltd.

                          Baxter Qiaoguang Healthcare (Guangzhou) Co., Ltd.

                          Baxter Healthcare (Tianjin) Co., Ltd.

·       Support PV Head in Baxter China to ensure Baxter China PV activities are in compliance with the China regulations and standards, and with Baxter policies and procedures at a local, regional and global level from.

·       Support PV Head in Baxter China set up and maintenance of local Pharmacovigilance system for Baxter China.

Core local PV activities

？  Ensure the case collection channel is maintained and tested in a routinely manner, such hotline, fax, company website, etc.

？  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, literature, 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

·       Monthly foreign cases line listings submitted online

·       Support to monitor the PV vendor (literature vendor, case handling vendor, etc.) performance, take part in vendor qualification activities.

·       Draft death case investigation report

·       Draft group AE investigation report

·       Draft case analysis report as appropriate

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

？ 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

？  SDEA

·       Ensure the implementation safety part of SDEA, by training to vendors, reconcile with vendors, and any other PV related actions included in SDEA.

？  Patient Support and Market Research Programs Activities

·       Collaboration with regional Operation/Compliance manager for the review of safety aspects of Market Research Programs Activities or patient support programs to ensure appropriate safety reporting to Global Patient Safety (GPS) and Regulatory Authorities, as required.

·       Ensure the implementation safety part of Patient Support and Market Research Programs Activities, by training to vendors, reconcile with vendors, and any other action included in Patient Support and Market Research Programs Activities.

？  PSURs

·       To submit individual PSUR to HA

·       Communicate with HA officer to obtain approval of PSUR

？  Provide input for Safety Committee Meeting

Interaction with key stakeholders

·       Build alignment and collaboration with local Regulatory Affairs, Medical Affairs, Clinical Operations, Quality Assurance, and Business Unit teams.

PV system process

·       Understand China PV regulation and Baxter China business

·       Work with PV head to improve PV process / system

·       Support business projects via ensuring proper PV process are followed

PV Training

·       Provide or coordinate PV training to Baxter employees, vendors and PV staff and documented, with local training Matrix maintained.

Qualifications

·       Excellent communication, consulting, and problem solving skills, including with regulators.

·       Fluent in English, both oral and written.

·       Strong interpersonal skills geared towards relationship development and co-operation.

·       Medicine, Pharmacy, or Clinical Science Bachelor degree or above in with working experience in nominated discipline and with medical, pharmacy, statistic or epidemiology related knowledge.

·       Knowledge of the PV relevant regulatory framework in China, and international PV relevant regulations and standards.

·       Minimum 1-3 years’ experience in Pharmacovigilance, preferably in similar role.

·       Ability to establish priorities and proceed with accomplishing objectives

·       Experience with a Global Safety Database.

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.