QPPV and Head Pharmacovigilance Excellence
QPPV and Head Pharmacovigilance Excellence
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Job Description
As the European Union (EU) and United Kingdom (UK) Qualified Person for Pharmacovigilance (QPPV) you will be accountable for AstraZenecas compliance with EU/EEA and UK regulatory requirements governing pharmacovigilance activities. Additionally you will lead the Pharmacovigilance Excellence team to ensure the optimal quality and compliance of the AZ Pharmacovigilance (PV) System globally.
Key Responsibilities
- EU & UK QPPV Responsibilities:
- Oversee AstraZenecas PV system to ensure compliance with EU/EEA and UK legal requirements and Good Pharmacovigilance Practice (GVP).
- Ensure the quality correctness and completeness ofkeypharmacovigilanceactivitiesand outputsfor example Product Information Risk Management Plans Periodic Reports Health Authority Queries and emerging safety concerns
- Act as a PV contact point for regulatory authorities on a 24hour basis.
- Head of Pharmacovigilance Excellence:
- Lead the Pharmacovigilance Excellence team to ensure and enhance the quality and compliance of the global PV system
- Provide crossfunctional expert Pharmacovigilance knowledge and maintain best practices across global and local networks.
- Contribute to the development and implementation of GPS strategy as part of the Patient Safety Leadership team.
- Build and sustain external relationships with regulatory authorities and partners to establish AstraZenecas Global Patient Safety (GPS) as industryleading.
Education Qualifications Skills and Experience
Essential:
Medical degree or Masters degree in a relevant life science discipline.
Extensive experience in pharmacovigilance/patient safety
Appropriate experience of acting as EU QPPV/Deputy QPPV preferably in large or midsize pharmaceutical company.
Excellent communication and influencing skills.
Desirable:
Expert reputation within the business and industry.
PhD in a scientific discipline.
Knowledge of technology development within the PV area.
Key Relationships:
Internal: Deputy EU QPPVs GPS TA product teams Chief Safety Officer Chief Medical Officer Regulatory Affairs.
External: EMA MHRA Other regulatory authorities external PV vendors and industry groups.
Date Posted
15May2025Closing Date
29Sept2025AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industryleading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.
Employment Type
Full-Time
