EU QPPV Pharmacovigilance Manager | PV Data & Safety Lead

Zoetis; Portugal; Presencial; EUR 70 000 - 110 000; Tempo integral

Resumo da oferta

Zoetis is seeking an experienced Pharmacovigilance professional to support global regulatory activities in Portugal. The role focuses on ADE reporting, signal management, and trending analyses for EU/US regulatory submissions.

The successful candidate will act as Deputy EU/UK QPPV, collaborate with cross-functional teams, and maintain PV systems to ensure compliance with international safety standards.

Qualificações

• Requires a veterinary medicine degree (DVM/VMD) with 5+ years in veterinary pharma and pharmacovigilance in the EU.
• Experience reviewing/regulatory guidance for ADE reporting and signal management is essential.
• Strong data analysis, reporting, and cross-functional collaboration abilities.

Responsabilidades

• Contribute to global pharmacovigilance activities including ADE reports, trend analyses, and regulatory submissions.
• Collaborate with signal management for validation activities to meet FDA/USDA/EU expectations.
• Prepare trending reports and advise on safety/efficacy adjustments for Zoetis products.
• Provide PV input for regulatory responses and advertising materials as needed.
• Maintain PV electronic systems and act as SME for assigned product groups.

Conhecimentos

ADE reporting

Signal management

Regulatory knowledge

Data analysis

Communication

Formação académica

DVM/VMD

Graduate degree in animal science/epidemiology

Ferramentas

PV database software

Database software

Descrição da oferta de emprego

Zoetis is seeking an experienced Pharmacovigilance professional to support global regulatory activities in Portugal. The role focuses on ADE reporting, signal management, and trending analyses for EU/US regulatory submissions.

The successful candidate will act as Deputy EU/UK QPPV, collaborate with cross-functional teams, and maintain PV systems to ensure compliance with international safety standards.