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
Completed education in Life Sciences (Bachelor's degree, or higher)
At least 2 years experience in the pharmaceutical industry, preferably in a global role
Experience in medical writing is an asset
Excellent verbal and written skills in German and English are mandatory
Strong communication skills with internal and external stakeholders
Highly organized, with the ability to manage priorities effectively in a fast-paced, dynamic environment
Proactive team player with a collaborative and solution-oriented mindset
Working with Valneva means being part of a global biotech company with a clear vision to make a meaningful impact in the world . At Valneva, you can expect a dynamic and innovative work environment characterized by an open, appreciative company culture and exciting, impactful assignments . Enjoy the benefits of flat hierarchies , an international atmosphere, and regular company events that foster collaboration and connection.
Additionally, we offer:
Work Life Balance: Flexitime & Compensation days
Financial perks: Performance-related bonus & Lunch vouchers
Health & Wellbeing: Free access to sports and fitness activities via myClubs& Office Massages
Join us and shape the future of biotechnology!
Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 52.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.
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PV Quality Assurance Manager (m/f/d) – Vienna, Austria in Wien Arbeitgeber: Valneva SE
Valneva SE ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Wien eine dynamische und innovative Arbeitsumgebung bietet. Mit flachen Hierarchien, einer wertschätzenden Unternehmenskultur und zahlreichen Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung, profitieren Sie von einem internationalen Team und regelmäßigen Firmenveranstaltungen, die den Zusammenhalt fördern. Genießen Sie zudem attraktive Benefits wie flexible Arbeitszeiten, leistungsbezogene Boni und Zugang zu Sport- und Fitnessaktivitäten.
