About this role
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
Requirements
- 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
Benefits
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.