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Case Management - Senior Manager
Thousand Oaks, CADescription:
Note:
Remote
Group Purpose
Knowledge and Skills
Basic Qualifications:
Top 3 Must Have Skill Sets:
Pay Rate- between $68- $78/Hr. on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
Note:
Remote
- 6 month initial contract length with possible extension
- Schedule - flexible, normal shift
- Title (Role) Case Management – Senior Manager
- Organization Global Patient Safety
- Ideal candidate: B.S 8+ YOE
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
- 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
Basic Qualifications:
- Doctorate degree and 4 years of directly related experience
- Master’s degree and 8 years of directly related experience
- Bachelor’s degree and 10 years of directly related experience
- 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Top 3 Must Have Skill Sets:
- PV & Global regulations
- Managing business partner relationships
- Strong communication skills
- Ability to work independently
Pay Rate- between $68- $78/Hr. on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"