Head QPPV Office and Deputy QPPV - St. Meinrad, IN, United States - Stellar Enterprises

James Miller

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James Miller

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Description

Head QPPV Office and Deputy QPPV - St. Meinrad, IN


At Boehringer Ingelheim, we are dedicated to developing innovative therapies and health solutions that are essential for the well-being of patients.

With a team of 52,000 colleagues worldwide, we maintain a family-owned company culture despite our size.


We are currently seeking a
Head QPPV Office and Deputy EU-QPPV to report to the EU Qualified Person for Pharmacovigilance (QPPV) and Head Regional PS & PV EUCAN/EM.

In this role, you will ensure that Boehringer Ingelheim's Pharmacovigilance (PV) System complies with global regulatory requirements in terms of structure and performance.


Job Details


As the Functional Quality Representative for Boehringer Ingelheim's broader Medicine organization, you will work with cross-functional colleagues from diverse backgrounds.

You will also have the opportunity to represent the Patient Safety Pharmacovigilance Department in front of your colleagues.


In collaboration with process owners, you will lead the development and management of processes and procedures to ensure PV quality and compliance, as well as PV inspection readiness.

As the head of the QPPV Office, you will identify team priorities and responsibilities to maintain oversight of the PV system, including training and PV system performance.

You will also ensure proper documentation in the Pharmacovigilance System Master File (PSMF) and handle audits and inspections efficiently.

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