Assoc, PV

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.

PV Quality Systems:
o To comply with the Baxter Pharmacovigilance Quality systems and policies.
o Ensure compliance with procedures for document management retention and archiving.
o Ensure all training requirements for the role are met.
o Ensure adherence to the BCP (Business Continuity Plan).
o With regards to third party agreements:
 Perform due diligence.
 ICSRs intake.
 Case Intake:
o Manage the receipt and capture process for adverse event (AE) and pregnancy report collection in the Pharmacovigilance safety database.
o Various sources of AEs include but are not limited to; spontaneously reported cases from patients, HCP, nurses, Baxter employees (including AEs associated with product complaints and AEs associated with medical queries), social media reports, partner companies and regulatory authorities; and solicited cases from patient support programs, market research programs, clinical studies and call centers.
o Assess the need for utilizing appropriate forms and questionnaires, complete appropriate forms and capture the information in the Pharmacovigilance safety database.

Perform the initial assessment on case validity, check for core case elements, perform duplicate checks and request for case deletion as required.
 Perform a seriousness assessment and case validity.
 Ensure all source documents are captured in the Pharmacovigilance safety database.
 Determine the requirement for follow up information and collect as much information related to a particular ICSR. Manage the process for collection and handling queries from the Global team.
 Re-assess the follow up information in the context of case validity, seriousness and; capture all follow up information and source documents in the Pharmacovigilance safety database.
 Perform ongoing tracking and local quality check of AE cases for follow up and submission requirements.
 At adverse event case receipt, analyze for safety information that requires immediate forwarding to Drug Safety Physician.
 Safety Risk Management Activities:
o Support Qualified Officer In charge with Implementing risk minimization measures locally as appropriate.
o Perform surveillance activities for any new potential safety information (e.g. similar AEs reported in a cluster of reports or multiple cases for one batch received in a short time frame) and escalate as per procedures.
 Other Responsibilities:
o Escalation of requests, received directly by local PV contact or indirectly (by Country RA/Country QA) from Regulatory Authorities relating to product safety, efficacy and quality must be disseminated to Qualified Officer In charge.
o Update the PvOI in charge of all pharmacovigilance activities and safety issues.

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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