Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Summary

#This is where, you make a difference !

As a Senior Pharmacovigilance Specialist at the future Vantive, you will be a part of the important GPS (Global Patient Safety) function and will interact and promote Pharmacovigilance internally, collaborating closely with the EMEA & LATAM Pharmacovigilance Director and Team members located in various countries. Your role will be primarily focused on the UKI. You will maintain an efficient Pharmacovigilance system meeting the European and National regulations and secure compliance with SOPs. You will act as the National Contact Person for Pharmacovigilance for UK MHRA.

In GPS function, we ensure a robust system is in place for the collection and communication to local authorities of adverse events and other drug-related safety information.

The goal is to introduce effective patient risk mitigations through labeling, patient/prescriber education, and/or risk management plans.

What you’ll be doing

• To fulfill responsibility of National Contact Person for Pharmacovigilance for UK MHRA and act as the contact person in case of inspections and for any request from MHRA,
• To act as the contact point for MHRA and HPRA regarding any query related to pharmacovigilance and/or drug product safety
• In collaboration with EU/UK QPPV and the GPS organization, maintain an efficient local Pharmacovigilance system in UKI countries meeting the European and national regulations and in compliance with SOPs / establish and maintain the UK Pharmacovigilance System Master File (PSMF)
• To ensure inspection readiness, participate in audits/Inspections, provide support responses to findings and implement corrective actions
• To act as team lead for UKI with oversight of all PV activities in UKI, including those performed by the other UKI team member
• To process all notifications of adverse drug reaction with a RenalCo medicinal product: collection, recording, documentation, follow-up, archiving
• To perform monthly reconciliations and quality checks with internal functions, partners, and vendors
• To closely monitor local compliance and ensures all efforts are made to achieve high compliance rates,
• To collaborate closely with the EMEA PV team members on above activities and provide any relevant information or support.
• Act as Back-up for EMEA Team members to support Regional PV operations.

What you’ll bring

• A master’s degree or equivalent in Medicine, Pharmacy or Life Science.
• Significant experience in PV is required with preferably, experience in Homecare program management (Patient support program)
• Good knowledge of Pharmacovigilance regulations and understanding of medical terminology
• Structured and organized approach to work and prioritization skills
• Ability to use computerized applications and systems, in particular Global PV Database
• Excellent collaboration skills with an ability to effectively interact and liaise with internal collaborators i.e. Global Pharmacovigilance, Regulatory Affairs, Country Quality Assurance, Business units, Legal Affairs.

What we can offer

• A challenging opportunity to participate in creating a new company !
• A chance to work in a diverse and experienced team with a great mix of people located in various countries. Joining the future Vantive means joining a team that you can truly learn from!
• A chance to further build your professional experience in the area of healthcare
• Internal training tailored to business needs and career goals

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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