Sr. Patient Safety Specialist

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About the role

Accountabilities • Maintain an effective local PV system compliant with local regulations and Good Pharmacovigilance Practice (GVP), including inspection readiness and business continuity. • Maintain and govern local patient safety procedural documents and ensure accurate local contributions to the Pharmacovigilance System Master File (PSMF). • Provide advanced operational oversight across PS processes, risk management, vendor oversight, and cross-functional collaboration. • Manage health authority interactions and ensure robust quality management, including CAPA, training, and documentation control. • Lead or mentor local PS staff and support local/global projects, analytics, and continuous improvement initiatives. Responsibilities Regulatory Intelligence and Governance • Maintain in-depth knowledge of local PV regulations and guidance; update regional lead and local teams on changes and escalate to Global Patient Safety as required. • Ensure local PV information is correctly reflected in the PSMF. Keep marketed status, Product Information/core data sheets, and safety commitments/conditions of use up to date. • Maintain and periodically review local PS procedural documents and related governance records (organization charts, job descriptions, CVs, training matrices/records). Patient Safety Operations and Compliance • Oversee ICSR processing from clinical and post marketing sources via monthly quality control, and timely submission of ICSRs and follow-ups to health authorities. • Support timely, compliant submission of other safety documents (e.g., PBRERs/PSURs, DSURs, signals, SUSARs, RMPs, DHPCs) to health authorities per local requirements. • Manage monthly patient safety compliance data and ensure accuracy, completeness, and timeliness of PV data submitted to authorities. Systems, Data, and Reconciliation • Maintain proficiency and oversee use of global PS systems and tools (e.g., Argus, Orbit, MyTime Portal, VQV, Nominated Signatory Portal, Cover, ERV, Veeva CRM, ECMS, Digital Assets Portal, PAL, Learning Management System). • Manage reconciliation processes (e.g., Organised Data Collection Programmes, Medical Information, Product Quality Complaints, Medical Science Liaison insights via Veeva free text) to ensure data transferred/received are accurate and complete. • Support development and use of reporting tools, dashboards, and analytics to monitor KPIs and identify operational improvements. Risk Management and RMP Implementation • Support creation, implementation, and maintenance of local RMPs and risk minimization activities in collaboration with cross functional teams; oversee educational materials associated with RMPs. • Maintain awareness of conditions of use, obligations, and other safety commitments, ensuring local fulfillment and documentation. Quality Management, Audit/Inspection, and CAPA • Support local SOPs and work instructions are in place, current, and aligned with global procedures; maintain filing and archiving practices for PS documentation. • Support audit and inspection readiness and execution; respond to findings and manage corrective and preventive actions (CAPA) through effectiveness checks. • Support annual update and testing of the local Business Continuity Process (BCP). • Maintain an after-hours AE reporting process for customers and authority queries. Health Authority and External Interface • Support managing interactions and queries from health authorities (e.g., ICSR-related inquiries, signals, RMP related educational materials); ensure prompt, complete responses. • Support external patient safety service providers to meet AZ and local regulatory PV requirements. • Oversee local safety management agreements; maintain Pharmacovigilance Agreement Listings (PAL). Tra

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