PV Quality Assurance Manager (m/f/d) – Vienna, Austria

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

Benefits offered by this job

Work-life balance

Bonus & lunch vouchers

Wellbeing programs

Job summary

Valneva SE is a specialty vaccine company focused on prophylactic vaccines for infectious diseases. We seek a Pharmacovigilance Quality Assurance Manager to drive compliance across PV systems and support QPPV under international regulations and Valneva standards.

You will maintain the PV QA system, provide QA support for PV activities, coordinate trainings, and lead internal PV audits and inspections in a fast-paced global environment.

Qualifications

• 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.

Responsibilities

• 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

Skills

PV quality assurance

Regulatory compliance

Document control

Auditing

German & English

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.