Especialista Farmacovigilância - Sao Paulo, Brasil - AstraZeneca

AstraZeneca

Empresa verificada

Sao Paulo, Brasil

há 3 semanas

Postado por:

Ana Silva

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Descrição

A AstraZeneca é uma das empresas biofarmacêuticas mais fascinantes do mundo.

Dos pesquisadores à equipe de vendas, dos técnicos de laboratório ao departamento jurídico, todos temos a missão de transformar ideias em ciência, ciência em medicamentos revolucionários que salvem e prolonguem a vida dos pacientes e beneficiem a sociedade.

Nosso portfólio é sólido e nosso pipeline é inovador com foco em medicamentos biológicos nas áreas Cardio-Metabólica, Respiratória e Oncológica.

The Patient Safety Specialist supports the Patient Safety Manager in the oversight of the local PV system, including any elements that are contracted to a third party.

This includes responsibility for ensuring the processes and systems necessary for the Patient Safety Specialist to fulfill their responsibilities, both internal and outsourced, for the management of AE reports, comply with global and local requirements; remain current with applicable regulations; and are followed consistently, by ensuring delivery of any training necessary.

The Patient Safety Specialist tracks system performance including regulatory compliance and provides periodic reports to management.

By attention to detail, quality and completeness, the Patient Safety Specialist ensures that adverse event information received locally contributes to AstraZeneca's knowledge of the safety profile of its products.

The Patient Safety Specialist reports to the Patient Safety Manager and may act as the Local Responsible for Pharmacovigilance before the local regulatory authority.

Principal Responsibilities:

Oversees and supports the Analysts in daytoday activities such as: receipt and management of adverse events received in the territory, including submission to the regulatory authorities and followup process.
Support the PS Manager in the coordination of the AstraZeneca Patient Safety Analysts local team.
May act as the Local Responsible for Pharmacovigilance on behalf of AstraZeneca Brazil.
Helps in the supervision of local contractors performing PV activities
Oversight of external party or parties where applicable within Brazil who are engaged in the collection, translation, entering of initial AE information into AZ systems, as appropriate, that originates from any relevant PV data source, and onward forwarding of the AE information to Global Patient Safety. A Patient Safety Specialist performs these tasks directly as necessary.
Develop and maintain effective business relationships with external parties in addition to tracking performance metrics including regulatory compliance.
Followup adverse events as necessary, providing new and updated information to GPS, and logging unsuccessful efforts.
Maintains local source documents in accordance with applicable record retention requirements.
Support the PS Manager, ensuring 24/7 business continuity for collection & reporting of AEs within the country (Brazil) of responsibility.
Act as the deputy contact for GPS in the country of responsibility (Brazil).
Executes CAPA plans relevant to the Patient Safety Specialist role as necessary, and oversees the development, implementation, and execution of any necessary CAPA plans by third parties that support the Patient Safety Specialist's area of responsibility.
Maintains and seeks out a thorough understanding of global and local requirements that relate to the Patient Safety Specialist role, identifying and communicating emerging needs to introduce process changes to remain compliant.
Provides PV expertise to the selection and qualification of any Patient Support Program organized within the countries.
Performs root cause analysis of deviations relevant to local PV processes.
Support the PS Manager as Point of contact to provide local expertise on AE reporting processes and standards to local country (Brazil) staff and related contractors/vendors according to AstraZeneca standards and local regulations.
Maintains oversight of vendors relevant for PV.
Shares best practices with other affiliates worldwide.
Streamlines and develops local processes as required.

Qualifications:

Extensive experience in pharmaceutical industry experience or equivalent with majority of experience in a PV functional role (e.g. 3 years).
Fluency in English language required.
Vendor management experience.
Proven expertise and experience in pharmaceutical regulations and R&D processes.

Education:

Life sciences degree.

Competencies:

Proven ability to organize workflow activities and manage multiple critical issues.
Awareness of and familiarity with industry principles of PV, drug development and pharmacology.
Computer literate with expert knowledge of PV database systems.
Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.
Ability to establish and maintain open relationships within the local and global organizations and wit