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 Operation

PV Training: NJO, PV training to new hirer, annual refresh training to all Baxter staff, customer facing staff, 3rd party, 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, 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 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

Others:

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

• Team meetings and meeting arrangements

• Monthly metrics update

• Fax, group mailbox, post, etc. daily checking

  
  

  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.

上班地址：上海