Deputy Eu Qppv

hace 1 semana

Barcelona, España AstraZeneca A tiempo completo

The Deputy EU QPPV deputises for the EU Qualified Person for Pharmacovigilance (QPPV), assuming QPPV responsibilities during their absence. Execute EU QPPV responsibilities for a portfolio of assigned Medicinal Products approved in the EU as delegated by the EU QPPV. Core accountabilities include oversight of pharmacovigilance (PV) data quality, product safety and risk management, involvement in regulatory submissions and documentation review and approval and the promotion of quality and compliance across patient safety team. The role also supports continuous improvement within PV processes.

**Typical Accountabilities**:

- ** Pharmacovigilance Oversight**: Supports the QPPV on the fulfilment of PV system oversight as required by applicable regulations
- ** Safety & Risk Management**: Monitor medicinal product safety profiles and risk minimisation activities.
- ** Regulatory Activities**: Support EU marketing authorisations, review safety information and regulatory reports.
- ** Inspection and audits**: Represent the EU QPPV in licensing partner audits and local HA inspections
- ** PV System Governance**: Is part of the PV governance teams related to products safety, procedural framework and quality and compliance
- ** Continuous Improvement**: Lead initiatives enhancing PV quality, compliance, and efficiency.

**Essential Requirements**:

- Master’s degree (or equivalent) in a relevant life science discipline
- Sufficient basic medical knowledge
- Extensive pharmaceutical industry experience in Patient Safety
- Detailed understanding of PV legislation
- Awareness of current pharmaceutical industry developments
- Excellent communication skills
- Project management experience
- Residency within the EU

**Desirable Requirements**:

- Medical degree
- PhD in a scientific discipline
- Recognised expert reputation in PV within the business and industry
- Extensive knowledge of the latest technical and regulatory expectations in PV

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