Case Management

2 weeks 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

#J-18808-Ljbffr


  • Case Management

    4 weeks 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)...


  • Thousand Oaks, United States ICONMA Full time

    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...


  • Thousand Oaks, United States TotalMed Staffing Full time

    We are seeking a Case Manager Coordinator for an assignment in Thousand Oaks California. Administrative Coordinators perform clerical tasks including typing documents, compiling and filing records, answering and making telephone calls, scheduling appointments and completing general office tasks. Duties vary according to employer needs but Administrative...


  • Thousand Oaks, United States MedPOINT Management Full time

    Job DescriptionJob Description SummaryReporting to the Outpatient Lead Clinician, the Outpatient UM Clinician is responsible for assuring a thorough review of outpatient precertification/preauthorization referrals for those members identified as having the need for outpatient services. The OP UM Clinician works closely with Medical Director to determine and...

  • Case Manager

    5 days ago


    Fair Oaks, United States USCRI Full time

    Job DescriptionJob DescriptionUS Committee for Refugee and Immigrants (USCRI) Rayo de Luz program is dedicated to providing unaccompanied minors who are pregnant or parenting, ages 0-18, with a supportive, nurturing environment in a residential shelter, daily education Monday - Friday, and supportive wrap-around services in Sacramento, CA. Our program is...


  • Thousand Oaks, United States Skyworks Solutions, Inc. Full time

    As a Project Manager 2, Engineering, you will be part of our New Technology Introduction (NTI) Team. Our goal is to ensure new technology manufacturing processes are qualified and released to production on time, with low risk and high yield while meeting targeted goals for size, cost and/or performance. Meeting these goals enables highly competitive New...


  • Thousand Oaks, United States ADVANCED BIO-LOGIC SOLUTIONS Full time

    Description Note: 100% REMOTE no time zone preference, sit anywhere in the US (Will be working with people in EST, PST and PR). Working 9am - 6pm 1 year contract, with possibility to extend AND conversion (for right candidate) Top 3 Must Have Skill Sets Excellent communication and organizational skills. Must have Pharma, BioTech or medical device...


  • Thousand Oaks, United States Amgen Full time

    **HOW MIGHT YOU DEFY IMAGINATION?** You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...


  • Thousand Oaks, United States CareerBuilder Full time

    Summary: The Supply Chain Project Manager (SCPM) will translate product variation strategy as determined by the Variation Lead for reportable changes for Global Distribution control. May also translate product launch/variation strategy as determined by the Regional Operations Lead to an executable implementation plan for launch/variation changes for Customer...


  • Thousand Oaks, United States Aditi Consulting Full time

    Summary: The Supply Chain Project Manager (SCPM) will translate product variation strategy as determined by the Variation Lead for reportable changes for Global Distribution control. May also translate product launch/variation strategy as determined by the Regional Operations Lead to an executable implementation plan for launch/variation changes for Customer...


  • Thousand Oaks, United States Aditi Consulting Full time

    Summary: The Supply Chain Project Manager (SCPM) will translate product variation strategy as determined by the Variation Lead for reportable changes for Global Distribution control. May also translate product launch/variation strategy as determined by the Regional Operations Lead to an executable implementation plan for launch/variation changes for...


  • Thousand Oaks, United States Axtria, Inc. Full time

    Job DescriptionJob DescriptionAxtria IntroductionAxtria is a global provider of cloud software and data analytics to the Life Sciences industry. We help Life Sciences companies transform the product commercialization journey to drive sales growth and improve patient healthcare outcomes. We are acutely aware that our work impacts millions of patients and lead...


  • Thousand Oaks, United States Axtria, Inc. Full time

    Job DescriptionJob DescriptionAxtria IntroductionAxtria is a global provider of cloud software and data analytics to the Life Sciences industry. We help Life Sciences companies transform the product commercialization journey to drive sales growth and improve patient healthcare outcomes. We are acutely aware that our work impacts millions of patients and lead...


  • Thousand Oaks, United States Axtria Full time

    Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications. Axtria is a global provider of cloud software and data analytics to the Life Sciences industry. We help Life Sciences companies transform the product commercialization journey to drive sales growth and improve patient healthcare...


  • Thousand Oaks, United States Axtria, Inc. Full time

    Job DescriptionJob DescriptionAxtria IntroductionAxtria is a global provider of cloud software and data analytics to the Life Sciences industry. We help Life Sciences companies transform the product commercialization journey to drive sales growth and improve patient healthcare outcomes. We are acutely aware that our work impacts millions of patients and lead...


  • Thousand Oaks, United States Axtria Full time

    Axtria Introduction Axtria is a global provider of cloud software and data analytics to the Life Sciences industry. We help Life Sciences companies transform the product commercialization journey to drive sales growth and improve patient healthcare outcomes. We are acutely aware that our work impacts millions of patients and lead passionately to improve...

  • Cca Case Manager

    1 month ago


    Sherman Oaks, United States Libertana Full time

    **JOB DESCRIPTION** - Position: CCA Case Manager - Pay Range: $23-$27 - Reporting To: Lead Case Manager, Director of Waiver Services - Work Type: Remote *** The Case Manager is responsible for the care coordination of clients for the ALWP clients under the Care Coordination Agency (CCA). Care coordination includes identifying, organizing, coordinating, and...

  • Marketing Manager

    4 days ago


    Thousand Oaks, United States W3Global Full time

    Job Description Job role: Marketing Manager The client has an immediate opening for a Marketing Manager to join their team! In this role, you will be responsible for leading all marketing activities including brand marketing, social media, product marketing, and public relations. You will work closely with the Director of Sales and Operations to create a...


  • Thousand Oaks, United States The Camden Center Full time

    Job DescriptionJob DescriptionCamden Case Management is currently seeking Mentors in Ventura. Qualified candidates will preferably have experience working in the mental health, addiction and/or coaching fields. Some supervision hours toward licensure may be available in this role.Mentor Description:With Camden Case Management, the mentor is the client’s...

  • Case Manager

    20 hours ago


    Fair Oaks, United States Akua Behavioral Health Full time

    AKUA BEHAVIORAL HEALTH INC. the leader in Holistic Drug, Alcohol and Mental Health Treatment, is now hiring Case Manager for our Sacramento, CA location. The right candidates will be team players with a positive attitude and passion for helping recovering individuals. *This position is Full-Time. We are looking for someone with their CADC or CCAPP. Please...