Team Leadership and Development: Lead and coach a local case intake team, providing clear goals, ongoing training, and performance feedback to maintain high standards and build future capability.
Case Intake Excellence: Oversee end-to-end intake, processing, and reporting of ICSRs from clinical and post-marketing sources, ensuring accuracy, completeness, and timeliness.
Regulatory Compliance and SOP Governance: Maintain up-to-date local procedures aligned with global standards; ensure consistent adherence to SOPs and readiness for assessments and reviews.
You will guide Local Case Intake Advisors during interactions with public health agencies. Serve as the senior point of contact for complex customer concerns and ensure commitments are fulfilled.
Performance Metrics and Ongoing Improvement: Monitor benchmarks and SLAs, analyze trends, and drive targeted improvements to elevate quality, speed, and reliability.
Quality Oversight and Audit Readiness: Conduct quality checks, address deviations, and implement corrective and preventive actions to uphold compliance and inspection readiness.
Cross-Functional Partnership: Serve as a trusted liaison to Medical, Regulatory, Clinical, and Commercial teams, providing patient safety expertise that informs decisions and risk management.
Global-Local Alignment: Communicate local changes and insights to global collaborators; ensure local information is accurately reflected in the Pharmacovigilance System Master File.
Risk Management and Educational Materials: Support delivery of Risk Management Plan commitments, including oversight of related safety communications and materials.
Business Continuity and Coverage: Ensure robust after-hours processes and team coverage so that AE reporting and regulatory responses continue uninterrupted.
Systems and Data Stewardship: Oversee use of global patient safety systems (such as Argus), ensuring data integrity, proper documentation, and compliant archiving.
Project and Innovation Contribution: Contribute to local, regional, and global projects that enhance case handling, leverage digital channels, and strengthen the overall safety framework.