AstraZeneca
Healthcare
LocalCaseIntakeAdvisor,GBSPatientSafety(Temporary-12months)
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“Local Case Intake Advisor, GBS Patient Safety (Temporary -12 months) at AstraZeneca. Skills: Patient safety, Pharmacovigilance, Regulatory compliance. Support intake of ICSRs. Support review of ICSRs”
What You'll Achieve.
Managed accurately; Managed efficiently; Full compliance with regulatory requirements
Industry & Context.
Problem-solving skills
Temporary - 12 months
What They're Looking For.
Must Have
Degree in Pharmacy, Medicine, or Science-related field, Fluency in English
Nice to Have
Vendor management experience, Audit and inspection support experience, Project work experience, Argus experience
What You'll Do.
Support intake of ICSRs
Support review of ICSRs
Support processing of ICSRs
Support reporting of ICSRs
Ensure compliance with GVP
Ensure compliance with AstraZeneca procedures
Ensure compliance with local health authority requirements
Support regulatory authority queries
Support reconciliations
Support literature screening
Support database screening
Support quality activities
Support compliance activities
Support audit readiness
Support inspection readiness
Support documentation
Collaborate with internal teams
Collaborate with service providers
Collaborate with external stakeholders
How You'll Work.
Team & Collaboration
Internal teams; Service providers; External stakeholders
Communication Scope
Written communication; Verbal communication
Full Job Description
At **AstraZeneca** , patient safety is central to everything we do. We are looking for a **Local Case Intake Advisor, GBS Patient Safety** to support local pharmacovigilance operations and help ensure adverse event reporting is managed accurately, efficiently, and in full compliance with regulatory requirements. Based in **Guadalajara** , this role supports local Marketing Companies and acts as a key link between local teams and the **GBS Patient Safety** function. The position requires **fluency in English**. ## **Key Responsibilities** You will support the intake, review, processing, and reporting of **Individual Case Safety Reports (ICSRs)** from clinical and post-marketed sources. You will help ensure compliance with **Good Pharmacovigilance Practice (GVP)** , AstraZeneca procedures, and local health authority requirements. The role also includes supporting regulatory authority queries, reconciliations, literature and database screening where required, quality and compliance activities, audit and inspection readiness, documentation and archiving, and collaboration with internal teams, service providers, and other external stakeholders. ### ## **What We’re Looking For** We are seeking a candidate with: * **A degree in Pharmacy, Medicine, or a Science-related field** * **Knowledge of pharmacovigilance and health authority regulations** * **Strong attention to detail and problem-solving skills** * **Excellent written and verbal communication skills** * **A collaborative, cross-functional working style** * **Fluency in English** Experience with **vendor management** , **audit and inspection support** , **project work** , or **Argus** would be an advantage. ### ## **Why Join AstraZeneca** This is a meaningful opportunity to contribute directly to **patient safety** while building experience in a global, science-led organization. You will work in a collaborative environment that values integrity, quality, and continuous learning, with the chance to make a real impact
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