Summary ：

Support Sr. PV manager 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. Represent as China PV head to external stakeholders. The main focus of this position will be on PV surveillance. This position represents and is responsible for the local Pharmacovigilance activities of products (drugs) manufactured / imported by 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 manager to establish and manage an effective Pharmacovigilance (PV) system for medicinal products in China. Continually and proactively improve and develop the PV system and department to meet the needs and requirements of Baxter, and Pharmacovigilance regulations and standards.
• Responsible for data Integrity and audit support related to GPV systems.
• Ensure all safety information at a local level is captured in the Global PV database within reporting timelines.
• Ensure appropriate liaison with local and national health authorities.

• 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.

• 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.

• 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.

• 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.
  

上班地址：上海