Local Case Intake Advisor

Job Title: Local Case Intake Advisor

Career Level - C
WORKING HOURS - US SHIFT WORKING HOURS

Introduction to role:
Are you ready to turn vigilance and precision into real-world patient impact? As a Local Case Intake Advisor, you will ensure that every safety signal is captured, processed, and communicated with speed and accuracy, protecting patients and strengthening our medicines’ lifecycle. Your work will directly influence how we respond to safety information and uphold the highest standards of compliance.

You will join a high-performing, digitally savvy team that partners across functions, harnessing new technology and smart ways of working to streamline and elevate patient safety operations. We value curiosity, clear communication, and decisive action. Do you thrive in a dynamic environment where attention to detail and accountability drive measurable outcomes?

Accountabilities:
- Local Case Intake Excellence: Ensure robust local processes for collection, reporting, and tracking of Adverse Events, including handling of Individual Case Safety Reports across clinical and post-marketed sources.
- Assess and process safety data from various sources. Distribute reports and metrics to internal and external collaborators following regulations and SOPs. This supports timely decision-making.
- Complaint Identification and Triage: Identify Product Quality Complaints and Product Security complaints, securing information needed for accurate AE reporting and resolution of critical issues.
- Regulatory and Collaborator Response: Provide timely, well-documented support to regulatory authorities and collaborators, maintaining clarity, speed, and compliance in all interactions.
- Compliance and CAPA Implementation: Implement Corrective and Preventative Actions for local non-compliance, including accurate processing of late logs, to strengthen operational reliability.
- Data Reconciliation and Quality Assurance: Perform reconciliations to confirm the accuracy of pharmacovigilance data transferred and received, safeguarding data integrity.
- Patient Follow-up and Documentation: Conduct manual follow-up using approved call scripts and resources; maintain strong archiving practices to ensure audit-ready patient safety documentation.
- Audit and Inspection Readiness: Contribute to Good Pharmacovigilance Practice and support audits and inspections, reinforcing a culture of preparedness and transparency.
- Knowledge and Training Stewardship: Complete required trainings, maintain access to relevant systems, and stay current on local regulations, guidance, product status, and safety obligations.

Essential Skills/Experience:
- Support provision of the following activities:
  - Pharmacovigilance activities including local processes, procedures and systems in place for collection, reporting and tracking of Adverse Events (AEs), handling of Individual Case Safety Reports (ICSRs) for AEs from clinical and post-marketed sources (including literature) and Organised Data Collection Programs.
  - Review, assessment and processing of safety data and information received from various sources, distributing reports and/or metrics onwards to both internal and external third parties following applicable regulations and standard operating procedures (SOPs), under guidance and support of the appropriate Local Case Intake Team Managers and/or senior team members.
  - Identification of Product Quality Complaint (PQC) and Product Security complaints, including collection of information necessary for AE complaint reporting.
  - Provide timely support in responding to queries from regulatory authorities, as well as internal and external collaborators, related to the Patient Safety function.
  - Implementation of Corrective and Preventative Actions in the event of local non-compliance and processing of completed late logs.
  - Reconciliations ensuring the accuracy of pharmacovigilance data that is transferred and received.
  - Undertake manual follow-up where required disseminating clear and accurate information based on approved call scripts and/or other AZ approved resources.
  - Archiving practices of patient safety documents.
- Actively contribute to maintaining the core components of Good Pharmacovigilance Practice, via contribution to all safety related processes and brand activities within countries of remit and being audit and inspection ready.
- Support the local PS team in relation to audits or regulatory authority inspections.
- Complete all required patient safety trainings in adherence to internal processes and external regulations, and obtain access to relevant systems, such as Safety Database, Human Resources systems, and other global or local systems commercial databases as appropriate.
- Maintain current and in-depth knowledge of:
  - Relevant country regulatory authority regulations
  - Global and local procedural and guidance documents
  - Marketed status of products in the local country and reference documents (i.e. Core Data Sheet)
  - Conditions, obligations and other commitments relating to product safety or the safe use of AZ products

Desirable Skills/Experience:
- Experience working in patient safety or pharmacovigilance operations within a pharmaceutical or clinical research environment.
- Familiarity with global safety databases and commercial systems (e.g., Argus, ARISg, Veeva Vault Safety) and related workflows.
- Strong analytical skills with a track record of data accuracy, reconciliation, and documentation control.
- Confident communicator able to work cross-functionally and respond effectively to regulators and external partners.
- Fluency in English and the local language; additional languages are an advantage.
- Degree in life sciences, pharmacy, nursing or a related field, or equivalent relevant experience.
- Knowledge of GxP and GVP frameworks and practical application in daily operations.

When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, our work has a direct impact on patients' lives. We empower our teams to perform at their peak by combining cutting-edge science with leading digital technology platforms. Our commitment to innovation drives us to explore new ways of working, creating partnerships and ecosystems that deliver exponential growth. With a focus on data, analytics, AI, machine learning, and more, we are transforming healthcare and making a meaningful impact every day.

Ready to take on this exciting challenge? Apply now and be part of a team that's changing lives!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.