Case Management - Senior Manager

Ampcus, Inc
United States, California, Thousand Oaks
Dec 20, 2024
Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team. Job Title: Case Management - Senior Manager (Remote) Location(s): Thousand Oaks, CA Responsibilites: 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 and 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: Line Management of Case Management staff Management of all ICSR processing globally for clinical trial and post-market cases by all case processing teams Ensure Vendor delivers high quality cases in a timely manner to meet all worldwide regulatory authority requirements Provide vendors with resources and training to perform their role Analysis and communication of case QC results Management of business partner relationships for case management Accountable for contract wording for case related data exchange Escalation of case related issues Providing subject matter expertise in the interpretation of regulations as it relates to case intake and processing Providing audit/inspection support for case management related activities 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 issue management and oversight for Case Corrections Tracker Ensure oversight and monthly measurement of Quality Control and Retrospective QA metrics Oversee performance monitoring and relay quality metrics to vendors Analysis of QC trends including actions/recommendations Generate, communicate, and archive report of QC findings Serve as subject matter expert for case management Next Generation/automation initiative. Provide subject matter expertise in the interpretation of regulations as related to case processing. Audit/inspection response subject matter expert for case related findings Ensure audit CAPAs and other actions/recommendations for ICSR processing, quality related measures and compliance issues are completed Actively participate and support audits/inspections Knowledge and Skills:* Proficiency in global regulatory requirements for pharmacovigilance Extensive people management experience Expertise in all aspects of case management Experience in managing business partner relationships Experience in managing/supporting inspections Presentation and communication skills Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook Education & Experience (Basic):* Doctorate degree and 4 years of directly related experience OR Master's degree and 8 years of directly related experience OR Bachelor's degree and 10 years of directly related experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.