EU QPPV Global Safety Lead — Strategy & Compliance

Amgen; Portugal; Presencial; EUR 70 000 - 90 000; Tempo integral

Resumo da oferta

A leading global biopharmaceutical company in Portugal is seeking an experienced Global Safety Senior Manager to provide operational support for pharmacovigilance oversight. You will ensure compliance with EU regulations and guidelines, review safety documents, and collaborate with local safety officers. The ideal candidate holds a PharmD or Master's degree and has substantial experience in pharmacovigilance and EU legislation.

Serviços

Vast opportunities for career development

Flexible work arrangements

Generous total rewards plan

Qualificações

• 6 years of directly related experience in Pharmacovigilance.
• Strong background in safety evaluation and aggregate reports.
• Ability to work effectively across countries and cultures.

Responsabilidades

• Provide operational support to the EU QPPV Office.
• Review and comment on EU RMPs and periodic reports.
• Coordinate updates of Annex H2.

Conhecimentos

Knowledge of EU/UK PV legislation

Pharmacovigilance best practices

English communication skills

Organizational abilities

Collaboration skills

Formação académica

PharmD or Master’s degree in healthcare/science

Descrição da oferta de emprego

A leading global biopharmaceutical company in Portugal is seeking an experienced Global Safety Senior Manager to provide operational support for pharmacovigilance oversight. You will ensure compliance with EU regulations and guidelines, review safety documents, and collaborate with local safety officers. The ideal candidate holds a PharmD or Master's degree and has substantial experience in pharmacovigilance and EU legislation.