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 - Manager
Location(s): Tallahassee, LF
Responsibilities:- 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:- 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.
- Perform other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by supervisor.
Key Activities:- Day-to-day vendor management issues.
- Interact with other local safety offices.
- Ensure case processing timelines for intake, triage, and submission are met.
- Assess workload to assist in resource management.
- Support onboarding and ongoing training of vendors.
- Attend management meetings with vendors.
- Support analysis of QC trends.
- Support generating, communicating, and archiving 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.
- Bachelor’s degree and 5 years of directly related experience.
- Associate’s degree and 10 years of directly related experience.
- High school diploma / GED and 12 years of directly related experience.
- Previous experience directly managing 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 identity, national origin, age, protected veterans, or individuals with disabilities.
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