Pharmacovigilance Case Intake Specialist (Local)

Astrazeneca Plc; Portugal; Presencial; EUR 36 000 - 54 000; Tempo integral

Resumo da oferta

AstraZeneca is seeking a Local Case Intake Advisor within our GBS Patient Safety team in Portugal, focusing on the intake and processing of Individual Case Safety Reports (ICSRs) at a local level to support designated AstraZeneca Marketing Companies.

You will act as a liaison between local teams and Global Patient Safety, ensuring compliance with internal procedures and external regulations while delivering high-quality pharmacovigilance operations across multiple channels.

Qualificações

• Degree in Pharmacy, Medicine, or Life Sciences.
• Knowledge of pharmacovigilance (PV) and health authority regulations.
• Familiarity with safety systems (e.g. Argus).
• Experience with audits/inspections is a plus.

Responsabilidades

• Manage and process adverse event reports and ICSR from post-marketed sources.
• Support Health Authority interactions and queries related to safety cases.
• Review, assess, and distribute safety data in line with regulatory requirements and SOPs.
• Contribute to Quality Management Systems, including audit readiness and compliance activities.
• Support pharmacovigilance activities across data collection programs and digital channels.
• Identify and manage product quality concerns (PQC) and related safety reporting.
• Perform reconciliations to ensure PV data accuracy.
• Collaborate with local Patient Safety teams and cross-functional stakeholders.

Conhecimentos

PV knowledge

Analytical mindset

Attention to detail

Communication skills

Cross-functional collaboration

Problem solving

Audits & inspections

Regulatory knowledge

Safety systems (Argus)

Multilingual (English, Italian)

Formação académica

Degree in Pharmacy, Medicine, or Life Sciences

Ferramentas

Safety systems: Argus

Descrição da oferta de emprego

AstraZeneca is seeking a Local Case Intake Advisor within our GBS Patient Safety team in Portugal, focusing on the intake and processing of Individual Case Safety Reports (ICSRs) at a local level to support designated AstraZeneca Marketing Companies.

You will act as a liaison between local teams and Global Patient Safety, ensuring compliance with internal procedures and external regulations while delivering high-quality pharmacovigilance operations across multiple channels.