As the European Union (EU) and United Kingdom (UK) Qualified Person for Pharmacovigilance (QPPV), you will be accountable for AstraZeneca's 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
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EU & UK QPPV Responsibilities:
- Oversee AstraZeneca's PV system to ensure compliance with EU/EEA and UK legal requirements and Good Pharmacovigilance Practice (GVP)
- Ensure the quality, correctness, and completeness of key pharmacovigilance activities and outputs, for 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 24-hour basis
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Head of Pharmacovigilance Excellence:
- Lead the Pharmacovigilance Excellence team to ensure and enhance the quality and compliance of the global PV system
- Provide cross-functional 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 AstraZeneca's Global Patient Safety (GPS) as industry-leading.
Education, Qualifications, Skills, and Experience
Essential:
Medical degree or Master’s 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 mid-size 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