Pharmacovigilance Compliance and Safety Operations Manager

3 weken geleden

Utrecht, Nederland Baxter Voltijd

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 position is a member of Global Patient Safety –Global Pharmacovigilance Compliance and Safety Operations. This role encompasses the management of Safety Operations, PV Technology and Data Management supporting Kidney Co.’s products globally. In addition, the manager works closely with the Director and the compliance team to support Quality Management System (QMS), compliance activities and PV inspections/audits worldwide.

The manager ensures that Safety Operations are appropriate in terms of structure and performance, to comply with global standards, policies and procedures related to pharmacovigilance.

What you'll be doing...

Safety Operations

Ensure that pharmacovigilance daily operations, including adverse event case processing, global literature search and submission of ICSR to Health Authorities worldwide comply with regulations. Manage global vendor in charge of the Global Safety Database to convert GPS business needs into user requirements and deliverables that will assist in defining and validating the configuration of the end solution. Manage global vendor in charge of the Global Safety Database ensuring that any quality deviation and or miss of KPIs is properly addressed and a CAPA is initiated if needed. Determine root causes of nonconformance and assist in developing effective problem solution strategies to ensure compliance with safety information reporting to HAs worldwide.

GPS PV Audit and Inspection readiness

Responsible and accountable for leading and or support in responding to PV audits/inspections (including North America) and for opening corrective actions/preventive actions (CAPAs) for Safety Operations activities.

PV System Compliance and GPS QMS:

has oversight responsibility of GPS QMS documents management and training processes, for Safety Operations, PV Technology and Data Management activities, including strategy and compliance, use of BAXU, GPS training assignments and training metric reports. has oversight for any agreement withs vendors related to Safety Operations and PV Technology and Data Management activities

What you'll bring...

Master’s Degree in life science with at least 5 years in safety vigilance/Pharmacovigilance Working experience with team management Strong knowledge of Pharmacovigilance Safety Systems (ARGUS, or other safety database applications) and electronic data capture systems. Excellent interpersonal skills that encourage teamwork Ability to work under strict deadlines and changing priorities and ability to multitask and prioritize changing workload for self and others Problem Solving- Identify priorities and key issues in complex situations, and formulate and execute issue resolution with minimal assistance Broad knowledge/understanding of relevant ICH guidelines, as well as FDA and EU Regulations Ability to interact effectively in a multifunctional and multicultural team setting. Experience working within a quality system to develop and optimize processes. Experience on PV vendor management. Ability to collaborate effectively in a complex matrix organization. Excellent analytical and problem-solving skills. Mature personality with excellent leadership and interpersonal skills Leadership experience in managing direct and shared resources, some at a geographic distance. Cultural sensitivity, patient but persuasive, cultural fit with values.

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