PSPM Support Associate

SAO Fortrea Brazil Limitada; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A leading global contract research organization is seeking motivated individuals to support the setup and management of clinical trial projects in São Paulo. Responsibilities include assisting with safety management plans and regulatory audits, as well as ensuring compliance with reporting regulations. Ideal candidates will be problem solvers with a passion for impacting patient lives. Join a collaborative team committed to enhancing the delivery of life-changing therapies.

Responsabilidades

• Provide support for the set-up, maintenance and close out of Global or Regional projects.
• Support the Global Safety lead in preparation of Safety Management Plans and other safety-specific plans.
• Assist in TMF management activities as required.

Descrição da oferta de emprego

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

• Provide support for the set- up, maintenance and close out of Global or Regional projects in clinical trial and / or in post marketing studies, where delegated by the Global Safety lead of PSS Management team.
• Support the Global Safety lead in preparation of Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans under supervision.
• Support the Global Safety lead in preparation of study specific job aids, instructions, trainings and templates
• Support systems set up during study start up and ongoing maintenance.
• Support the Global Safety lead with project specific functional management for assigned projects (access requests, training assignment etc.)
• Support Global Safety lead with reconciliation of safety databases, if appropriate.
• Support Global Safety Lead in drafting / modifying and delivering safety presentations as required, to external and internal stakeholders.
• Support the Global Safety lead in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics / data are provided.
• Assist in TMF management activities as required.
• Support the Global Safety lead in the preparation of safety documentation for internal, client or regulatory audits.
• Maintains a comprehensive understanding of Covance PSS Standard operating Procedure (SOPs) and other relevant controlled documents.
• Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.
• Demonstrate role-specific competencies on a consistent basis.
• Demonstrate company values on a consistent basis.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.