PV Quality Assurance Manager (m/f/d)

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.

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