- Location
- Vienna, Vienna, Austria · published
- Type
- Full-time
- Department
- IT
- Seniority
- Manager
- Source
- Workable
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 departments
- Drive continuous improvement initiatives related to PV quality, processes, and compliance
Benefits
Work Life Balance: Flexitime & Compensation daysFinancial perks: Performance-related bonus & Lunch vouchersHealth & Wellbeing: Free access to sports and fitness activities via myClubs & Office Massages