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QPPV Office Lead (f/m/d)
Bavarian Nordic · Martinsried, Germany
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Job description
As the QPPV Office Lead (f/m/d), you will play a key role with maintaining oversight of the Pharmacovigilance System, promoting continuous inspection readiness and compliance activities and ensuring continuity of QPPV oversight and compliance.
Your tasks and responsibilities
Serve as a senior member of the QPPV Office ensuring effective execution of pharmacovigilance (PV) governance and oversight activities
Maintain in-depth knowledge of global and local pharmacovigilance obligations and regulatory requirements and lead the implementation of regulatory changes impacting the PV system
Support Process Excellence and Continuous Improvement by developing, maintaining and continuously improving PV governance frameworks and processes
Monitor global and regional pharmacovigilance regulations, guidance documents, inspection findings, industry trends and PV innovations (e.g. EMA, FDA, ICH, CIOMS and WHO)
Coordinate impact assessments for new pharmacovigilance regulatory requirements and support the development and maintenance of PV intelligence dashboards and trackers
Act as the key interface between the QPPV Office, local affiliates, Quality Assurance and third-party service providers supporting local PV activities
Support the management of the Local Person responsible for Pharmacovigilance (LPPV) network and ensure oversight of outsourced local pharmacovigilance activities
Coordinate governance meetings and LPPV compliance reviews
About you
Degree in Natural Sciences, Pharmacy, Nursing or a related scientific discipline
5–7 years of pharmacovigilance experience within the pharmaceutical industry
Strong knowledge of domestic and international pharmacovigilance laws and regulatory requirements
Demonstrated experience supporting QPPV activities, PV intelligence and LPPV network management
Experience leading cross-functional compliance or quality improvement initiatives is preferred
Excellent written and verbal communication skills in English and the ability to work effectively in a dynamic cross-functional environment
Continuous improvement mindset with a proactive, self-driven, accountable, open minded, adaptable and eager-to-learn approach including strong decision-making skills
To succeed in this role, you are a purpose-driven and quality-focused professional with a hands-on approach and a passion for learning and taking ownership of new projects. You enjoy working with document management and oversight tools to support QPPV oversight and have a passion for anticipating and identifying compliance trends and risks. You are motivated by driving operational excellence and enjoy collaborating with stakeholders to strengthen pharmacovigilance governance in a dynamic environment.
What We Offer
We are proud of our impact and know it takes time to get there. At Bavarian Nordic, you will find:
A flexible, inclusive and international work culture
Remote work with up to 20% travel (including to the office in Martinsried, Germany)
Opportunities to grow – both personally and professionally
A sense of purpose in your everyday work
A team that values authenticity, curiosity and courage
The incumbent of this role is offered the potential to develop into the Deputy QPPV role
Ready to Make an Impact?
We would love to hear from you! Apply by submitting your CV in English– no cover letter required. Interviews are held on an ongoing basis, so do not wait too long.
Applications submitted via email will not be considered.
We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position.
Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America.
Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
For more information, visit www.bavarian-nordic.com
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