(Sr) Mgr, PV

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Summary:

As the Senior Manager of Pharmacovigilance you will be responsible for establishing maintaining and continuously improving the PV system for Baxters drug products in China. You will act as the local Qualified Person for Pharmacovigilance (QPPV) per China GVP ensuring full compliance with local regulations and global policies. You will lead the China PV team serve as the primary contact for health authorities on drug safety matters and drive risk management and cross-functional collaboration across the product lifecycle.

Roles and responsibilities:

• Take the overall responsibility of China Hong Kong and Taiwan Pharmacovigilance (PV) to be responsible for set up operation and continuous improvement of PV system and ensure PV activities in Baxter China are complaint with local regulations and standards Good Pharmacovigilance Practice (GVP)and with Baxter policies and procedures.
• To fulfil the requirements as the Local Qualified PV Responsible for Baxter China as per local legislation and Good Pharmacovigilance Practice (GVP).
• Responsible for the set-up maintenance and operation of the local PV system in compliance with China GVP for Baxter China being the Marketing Authorization Holder for drug products.
• To ensure that any information relevant to the benefit-/risk evaluation of a medicinal product is provided to the regulatory authorities in China in a timely fashion.
• Represent Baxter PV China in meetings with external and internal stakeholders.
• To supervise all relevant PV activities performed in China support the improvement and harmonization of processes across the countries and ensure maintenance of an efficient PV system according to national regulations.
• To manage China Hong Kong and Taiwan PV team. To allocate adequate resources and budget in close collaboration with local controllers with the validation of regional PV Head and the support of regions resources.
  

Qualification

• Medicine Pharmacy epidemiology or other relevant professional background bachelors degree or above or Intermediate and above professional and technical titles
• Expert knowledge of the PV relevant regulatory framework in China and sound knowledge of international PV relevant regulations and standards.
• Be familiar with Chinas pharmacovigilance related laws regulations and technical guidelines have good knowledge and skills of pharmacovigilance management and comprehensive understanding of international PV related regulations and standards
• Minimum 5 years experience in Pharmacovigilance
• Excellent communication consulting and problem-solving skills including with regulators.
• Strong interpersonal skills geared towards relationship development and co-operation.
• Strategic thinking balanced with hands-on operational oversight.
• Fluent in English both oral and written.
• Ability to work well in a matrix and regional / virtual team environment.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

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