Qppv and Head Pharmacovigilance Excellence
hace 7 días
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**
- ** 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
- ** 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
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