PV Quality Assurance Manager (m/f/d)

Valneva SE; Wien; On-site; EUR 47,000 - 57,000; Full time

Benefits offered by this job

Work Life Balance: Flexitime & Compens

Financial perks: Bonus & Lunch Vouch

Health & Wellbeing: Sports & OfficeMas

Job summary

Valneva SE, a global biotech company, seeks a Pharmacovigilance Quality Assurance Manager to drive PV compliance and enhance the global PV system in line with international regulations and Valneva standards.

The role oversees QA for PV activities, audits, trainings, and documentation, and supports inspections. German and English fluency, strong communication, and a collaborative mindset are essential. Based in Austria, on-site with flexible work considerations.

Qualifications

• Bachelor's degree or higher in Life Sciences or related field.
• 2+ years in the pharmaceutical industry, preferably global.
• Experience in medical writing is advantageous.
• Excellent verbal and written skills in German and English.
• Strong communication and organizational abilities.

Responsibilities

• Maintain and improve the Pharmacovigilance Quality Management System.
• Provide QA support for operational PV activities, including document control and CAPA oversight.
• Coordinate PV trainings and manage PV documentation and SOPs.
• Plan internal PV audits and partner qualifications to ensure compliance.
• Support PV inspections, PASS activities, and PSMF maintenance.
• Assist the QPPV with PV operational matters.
• Act as a key contact for internal stakeholders to ensure PV compliance.
• Drive continuous improvement of PV quality and processes.

Skills

German language

English language

Communication skills

Team collaboration

Organized

Education

Bachelor's degree in Life Sciences

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 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 aglobal biotech companywith a clear vision to make a meaningfulimpact in the world. At Valneva, you can expect a dynamic andinnovativework environment characterized by an open, appreciative company culture and exciting,impactful assignments. Enjoy the benefits offlat hierarchies, an international atmosphere, and regular company events that fostercollaborationand 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.