Sr. Manager APAC PV Operations and ANZ PV LeadReq # JR - 023996 Location Old Toongabbie, New South Wales, Australia Additional Locations 38 Job Category Patient Safety Date posted 07/27/2020
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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.
This is an exciting newly created senior role to lead our ANZ PV function with additional responsibilities on the APAC leadership team in a senior operational capacity. This is a rare opportunity for you to bring your commercial mindset and business partnership skills to a pivotal local and regional role.
In this dual role you will support the implementation of strategies and processes to optimise the APAC PV function and its alignment to Global Patient Safety.
This will have you playing a lead across the implementation of consistency standards, processes and activities. Additionally, you will the local Qualified Person responsible for PV (Local QPPV) in Australia and New Zealand. This will have you, ensuring compliance with local regulations and standards pertaining to PV, communication of drug product safety related information, performing drug product risk minimization activities in business partnering and working closely with key areas such as Medical & Regulatory Affairs, Quality and Legal.
Key responsibilities include:
APAC PV Operations Lead:
- Regional PV Subject Matter Expert for Patient Support and Market Research programs, Quality Management Reviews
- Preparing and monitoring operations metrics for the region
- Lead role for learning across PV in the regional. This includes coordination of training programs and ensuring regional and global standards are met by the team
- Involvement as a key stakeholder in- cross regional activities related to Global Patient Safety
- Leading regional PV projects and programs
ANZ PV Lead:
- Establishment and maintenance of an effective PV system in compliance with local and global regulatory requirements
- Main point of contact to with Health Authorities in Australia and New Zealand
- Adverse event handling and ADR submission to the regulatory authorities
- Risk Management activities
- PV inspections and audits, training and compliance
- Third party agreement alignment
Key Requirements for the role include:
- Deep knowledge and experience in PV at a senior level in the ANZ market and Locally Qualified in Australia. APAC regional and or global experience is also highly desired. This includes understanding of best practices and relevant regulations
- A commercially aligned mindset with excellent problem solving and analytical skills
- Project and process management skills and the ability to collaborate well through complex assignments
- Knowledge of ICH guidelines and other worldwide safety regulations
- Experience with global safety databases
- Advanced relationship management and communications skills in particular managing & influencing regulators, executives and cross divisional leaders
- At Baxter we know that people are critical to our success. For this reason, we have a highly supportive culture with focus on developing the careers of our people. The company also promotes an environment to allow autonomy, achievement, collegial support and sharing within a rewarding work environment.
- A Bachelor’s degree in Pharmacy or Medical related areas is highly desired
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.