01Overview
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
