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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Case Management - Manager
Remote, CA US
Posted: 10/01/2024
2024-10-01
2024-11-08
Employment Type:
Contract
Job Category: Pharmacovigilance (PV)/Drug Safety
Job Number: 4053
Job Description
Our client is looking to add a Case Management - Manager to their team on a contract basis. Length of contract: 6 months with possible extension.
Responsibilities:
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
Responsibilities:
- 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
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
- Previous experience directly managing teams, projects, programs or directing the allocation of resources
- 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