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Case Management

4 months ago

Thousand Oaks, United States Dale Workforce Solutions Full time

Title (Role) Case Management - Manager Organization Global Patient Safety Location: Remote • Act as US/EU local safety office and FDA/EMA point of contact for safety reporting • Submission of all individual case safety reports to FDA/EMA, business partners (license partners) and vendors • Support interactions with, business partners (license partners) and vendors for all case intake and processing activities • Vendor oversight of all case intake processing activities and case quality including analysis and reporting of trends in quality measures • Ensure vendor compliance with approved processes and training requirements • Audit & external inspection support Job Summary Responsible for: • Support ICSR processing to ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements • Provide vendors with resources and training to perform their role • Support the analysis and communication of case QC results • Lead development and delivery of training materials for case management conventions • Support resolution of case related specific queries • Management of multiple business partner relationships for case management • Support reviews of contract wording for case related data exchange • Monitoring compliance in regard to regulatory submissions and/or contractual wording for data exchange • Assign tasks within Case Management to direct and indirect reports • Support management of staff within Case Management • Escalation of case processing issues • Audit & external inspection support • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness • Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Key Activities • Day-to-day vendor management issues • Interact with other local safety offices • Ensure case processing timelines for AE intake, triage and submission are met • Assess workload to assist in resource management • Support on-boarding and on-going training of vendors • Attend management meetings with vendors • Support analysis of QC trends • Support generating, communicating, and archiving of reports of QC findings • Support audits of CAPAs and other actions/recommendations for ICSR quality related measures • Perform case review as required • Lead development and delivery of convention-related training material • Support training of local office staff • Perform US case follow up activities • Perform BP reconciliation as required by safety agreement • Generate and distribute performance metrics (submission compliance, volumes, turnaround times) • Support reviews of contract wording for case related data exchange • Support regulatory inspection and support for vendor audits/inspections • Oversee performance monitoring and relay metrics to vendors • Support analysis of QC trends including actions/recommendations • Generate, communicate, and archive report of QC findings Knowledge and Skills • Understanding of global regulatory requirements for pharmacovigilance • Project leadership experience • Competence in safety systems • Experience in supporting inspections or internal audits • Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook

Education & Experience (Basic) Master's degree and 3 years of directly related experience OR Bachelor's degree and 5 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience AND Previous experience directly managing teams, projects, programs or directing the allocation of resources

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