Case Manager Pharma Background
Case Manager Pharma Background
Posted on :
01-10-2024
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Job Description
Case Manager Remote Description: 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 ysis 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 regarding regulatory submissions and/or contractual wording for data exchange ign 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 Daytoday vendor management issues Interact with other local safety offices Ensure case processing timelines for AE intake triage and submission are met ess workload to ist in resource management Support onboarding and ongoing training of vendors Attend management meetings with vendors Support ysis 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 conventionrelated 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 ysis of QC trends including actions/recommendations Generate communicate and archive report of QC findings Knowledge and Ss 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) Masters degree and 3 years of directly related experience OR Bachelors degree and 5 years of directly related experience OR ociates 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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Employment Type
Full Time
Key Skills
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