Local Case Intake Team Manager, GBS Patient Safety

Job Title: Local Case Intake Team Manager GBS Patient Safety

Career Level: D2

Introduction to role:

Are you ready to lead a high-performing team that safeguards patients by ensuring every adverse event report is captured assessed and acted on with precision In this role you will turn rigorous pharmacovigilance into real-world impact by enabling timely compliant case handling that helps bring innovative medicines to those who need them most.

You will guide a team at the forefront of patient safety working across markets to uphold regulatory standards strengthen our safety system and maintain trusted partnerships with Health Authorities. As our pipeline grows and new launches accelerate your leadership will ensure our local case intake operations stay robust responsive and inspection-ready. How will you raise the bar for quality speed and consistency across diverse markets

Accountabilities:

- Team Leadership and Performance: Lead coach and develop a local case intake team to deliver high-quality timely case processing; set clear expectations and provide ongoing feedback.

- ICSR Oversight and Timeliness: Ensure rapid and accurate intake processing follow-up and submission of Individual Case Safety Reports in line with regulations internal standards and agreed KPIs/SLAs.

- Health Authority Engagement: Oversee and support interactions with Health Authorities; act as the escalation point for complex queries to protect regulatory relationships and ensure prompt resolution.

- Quality and Audit Readiness: Conduct quality checks on completed cases; maintain process documentation; prepare the team and evidence for audits and inspections with zero surprises.

- Metrics and Continuous Improvement: Monitor local case intake KPIs analyse trends and drive targeted improvements that enhance accuracy cycle time and compliance.

- SOP and Process Governance: Implement and maintain current local SOPs and procedural documents; ensure alignment with global processes and timely updates when guidance changes.

- Regulatory Vigilance: Maintain deep knowledge of local pharmacovigilance legislation and advise regional and global stakeholders on changes that impact operating practices.

- System and Data Stewardship: Ensure correct reflection of local PV activities in the Pharmacovigilance System Master File; safeguard data integrity across patient safety systems and repositories.

- Cross-Functional Collaboration: Build strong relationships with Medical Regulatory Marketing and Sales to embed patient safety requirements into operations and materials including those linked to Risk Management Plans.

- Training and Capability Building: Ensure team completion of all required training including global systems (e.g. Argus); mentor new Case Intake Advisors and sustain a culture of learning.

- Coverage and Continuity: Maintain effective after-hours and coverage plans to guarantee continuous AE intake and rapid response to authority questions at all times.

- Documentation and Archiving: Oversee proper filing and archiving of patient safety documents to meet regulatory and internal standards.

- Product and Reference Knowledge: Keep up-to-date with marketed status and reference documents to support accurate case assessment and reporting.

- Safety Agreements and Studies: Support local safety management agreements and clinical study protocols to meet reporting obligations.

- Literature and Signal Support: Support literature surveillance for potential adverse events and ensure appropriate upgrading of non-serious events according to the Always Serious List.

- Issue Management: Ensure timely corrective and preventive actions for any non-compliance or SLA breaches; share learnings to prevent recurrence.

- Global and Regional Projects: Contribute to ad hoc local regional and global initiatives that evolve case handling practices and harmonise ways of working.

Essential Skills/Experience:

- Degree Qualified Pharmacy/ Medical/ Science

- Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry

- Thorough knowledge of the current pharmacovigilance and regulatory developments

- Experience in working cross-functionally

- Ability to set and manage priorities resource goals and project initiatives

- Ability to influence strategically to obtain desired outcomes while maintaining effective positive organisational relationships

- Excellent attention to detail

- Excellent written and verbal communication skills

Desirable Skills/Experience:

- Degree Qualified Pharmacy/ Medical/ Science

- Thorough knowledge and experience of pharmacovigilance within the pharmaceutical industry

- Thorough knowledge of the current pharmacovigilance and regulatory developments

- Experience in working cross-functionally

- Ability to set and manage priorities resource goals and project initiatives

- Ability to influence strategically to obtain desired outcomes while maintaining effective positive organisational relationships

Why AstraZeneca:

Join a team where patient needs guide every decision and where bold science meets smart execution. You will work with colleagues from diverse disciplines around the same table combining insights and technology to shape safer care across key disease areas. Expect the pace and ownership of a nimble operation backed by the resources of a global leader with room to test learn and move quickly. We value kindness alongside ambition creating an environment of trust and challenge that helps you stretch your expertise while delivering tangible benefits for patients and healthcare systems.

Call to Action:

Lead a team that turns vigilance into impact and help speed life-changing medicines to patientsstep forward and make this pivotal role yours today.

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.