Job Description

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You\'ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter\'s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives\xe2\x80\x94where your purpose accelerates our mission.

This position is a 16 month contract with benefits and can work Remote.

Your Role at Baxter

This is where your work saves lives The research we do and the products we develop improve outcomes for patients around the world. As a Regional Coordinator at Baxter, your work contributes directly to making a significant impact on others. We collaborate cross-functionally and lead by influence. Whether guiding a team through a project or leading teams directly, our research and development team is responsible for influencing others to achieve results! This is a position in the Pharmacovigilance Agreements (PVA) team in the QPPV Office. It has direct responsibility for management of the formulation, review, update, and compliance of Pharmacovigilance Agreements (PVAs) for potential and active External Party activities across all Baxter therapeutic areas in the Americas region (US, Canada, Latin America). This role manages all workflows related to PVAs in the region in collaboration with the regional business, Patient Safety, and other functions, as well as the process requirements for registering all patient support and market research programs (PSP/MRP) with GPS in the region. What you\'ll be doing:

• Communicate and negotiate directly with co-developers/co-marketers/partners (e.g. distribution partners) and patient support program (PSP) / market research program (MRP) vendors (External Parties) related to development, implementation and maintenance of PVAs
• Support development and maintenance of standard PVA templates for use at global and local level.
• Collaborate with other Baxter businesses/functions and GPS to ensure that

• new/planned business/commercial relationships are notified to GPS
• agreements appropriately address PV obligations.

• Inform GPS teams of new PVAs, including PVA commitments and contractual obligations, and any changes to existing PVAs
• Train local PS staff and other Baxter internal staff, as required, on PV obligations in new or updated PVAs/PSPs/MRPs and on process. Support planning, development, and maintenance of training material.
• Make registrations for Americas region in the PVA global repository and the PSP/MRP global repository, in collaboration with local PS when required.
• Answer internal (GPS) and external (Baxter business and External Party) questions related to PVAs and PSPs/MRPs registered with GPS,
• Ensure implementation of and support maintenance of GPS Global Quality Procedures (GQPs) and Guidance Documents/Job Aids related to External Party Agreements (PVAs, PSP/MRP agreements).
• Provide support as subject matter expert regarding PVAs and PSPs/MRPs for internal audits and external inspections by regulatory authorities in the region, as required.

What you\'ll bring:

• Bachelor\xe2\x80\x99s degree, or more advanced degree in relevant life science discipline, e.g. Pharmacist or Registered Nurse.
• 5+ years\xe2\x80\x99 experience in the pharmaceutical industry in pharmacovigilance (preferred) and/or related field required. (e.g. regulatory or medical/clinical affairs, legal, quality).
• 2+ years\xc2\xb4 experience with negotiation, creation, and management of Pharmacovigilance Agreements.
• Exposure to working relationship with regulatory authorities in the Americas and other region.
• Fluent in English is required. Fluent in Spanish and/or Portuguese is preferred.
• Strong knowledge of pharmacovigilance principals with at least 3+ years working knowledge of regional/local and global pharmacovigilance regulations and guidance documents.
• Experience with contract formulation and negotiation.
• Excellent oral and written communication skills.
• Interpersonal and collaboration skills, including ability to interface with and influence other internal groups.
• Ability to manage projects in a matrix environment with both internal and external partners.
• Ability to effectively train and mentor others
• Excellent technical system skills (e.g. spreadsheets, databases, Share Point, online research).
• Exercise independent judgment and attention to details
• Excellent problem-solving/strategic planning skills, interpretation and application of regulations, guidance, and best practices.
• Experience establishing compliance with pharmacovigilance procedures and systems with demonstrated leadership in assigned areas of responsibility.

#LI-MS1 Reasonable Accommodations 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. Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. 098070
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