长沙招聘

Main Responsibilities

Support PV Head in Baxter to take the overall responsibility of China PV 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.

PV surveillance

• 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

• Review death case investigation report

• Review group AE investigation report

• Review case analysis report as appropriate

• Review literature case report

• Review safety section of the label

• Review safety summary for license renew

• Collaborate with the China Regulatory Affairs groups to ensure the PSUR/PBRER Schedules are maintained. Review PSUR/PBRERs/Aggregate Safety Reports as appropriate, be aware of safety issues and changes in Reference Safety Information, and ensure timely submission according to local regulations.

• Provide local input for local RMP with support from GPV

• Prepare PV annual report for MAHs with support from GPV

• Provide PV support for clinical study

• Coordinate drug intensive monitoring activities for new products.

 

Interaction with key stakeholders

• Forward any Health Authority (HA) Assessment report or query to both GPS and the Regional Director PV - APAC, and coordinate the response back to the HA.

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

• Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the Local Regulatory Authority to the Regional PV Director as appropriate. Collaborate with appropriate departments to identify the resources and expertise needed to address/respond the question.

• Participate in Issue Management teams as required.

 

Set up and improve PV process

• Create, implement and update local Pharmacovigilance related procedures, as required.

• Oversight of marketing activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential AEs (e.g. market research surveys, internet sites).

• Ensure awareness of changes in regulations which may have an impact on PV activities and responsibilities. Inform the regional PV groups of any changes to local laws and regulations regarding Pharmacovigilance.

 

Ready for Inspection and Audit

• Participate in PV audit schedule and other PV audits and inspections as required. Assist in all audit preparation activities, including close out of any audit action items.

• Provides support to other Baxter functions in the auditing of external customers where PV falls within the scope of the audit plan, for example 3rd Parties as per SDEAs.

 

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.

• Expert knowledge of the PV relevant regulatory framework in China, and sound knowledge of international PV relevant regulations and standards.

• Minimum 3-5 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.