This listing was posted on Professional Diversity Network.
Case Management - Senior Manager
Location:
Thousand Oaks, CA
Description:
Case Management - Senior Manager Location: Thousand Oaks, CA/Remote Duration: 12 months with possible extension Description: Organization Global Patient Safety Group Purpose 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 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 As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to Professional Diversity Network
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Case Management - Senior Manager
Case Management - Senior Manager is a Executive Manager Job at Iconma located in Thousand Oaks CA. Find other listings like Case Management - Senior Manager by searching Oodle for Executive Manager Jobs.
Case Management - Senior Manager is a Executive Manager Job at Iconma located in Thousand Oaks CA. Find other listings like Case Management - Senior Manager by searching Oodle for Executive Manager Jobs.