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Posted 2d ago•Vienna, Vienna, Austria
PV Quality Assurance Manager (m/f/d)
MiddleOn-site (Vienna)Salary undisclosed
Job Description
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
Responsibilities
The Pharmacovigilance Quality Assurance Manager is a strategic role that drives enhanced compliance throughout the PV domain to support the obligation of the Marketing Authorization Holders and appointed QPPV, to maintain and improve a Global PV system in accordance with international regulations and Valneva standards.
- Maintain and continuously improve the Pharmacovigilance (PV) Quality Management System in compliance with global regulations and internal standards
- Provide QA support for operational PV activities, including document control, archiving, deviation management, and CAPA oversight
- Coordinate and deliver PV trainings while managing PV-related documentation and SOPs
- Plan and conduct internal PV audits as well as partner qualifications and audits to ensure regulatory and contractual compliance
- Support PV inspections, PASS activities, and maintenance of the PSMF
- Support the QPPV with PV operational matters
- Act as a key contact for internal stakeholders, fostering collaboration and PV compliance across d
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