Case Management – Director

Location

California | thousand oaks

Position type

Direct Placement

Job Description

Title (Role) Case Management – Director
Organization Global Patient Safety
Location: Remote

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
•Management of Global Case Management Group
•Accountable for vendor delivering high quality cases in a timely manner to meet all worldwide regulatory authority safety reporting requirements
•Management of Vendor/business partner relationship and successful issue management
•Accountable for contract wording and compliance for case related data exchange with business partners
•Providing audit/inspection support for case management related activities
•Providing subject matter expertise in the interpretation of regulations as it relates to case processing
•Escalation to compliance council for case related issues
•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

Key Activities
•Oversee day-to-day issues management process; final decision on escalated issues
•Business lead for vendor relationship; attend all joint management meetings
•Responsible for the growth and development of direct reports.
•Liaison with affiliates as needed regarding case management issues with regard to product safety issues.
•Oversee / manage correspondence associated with AE reports involving possible litigation.
•Ensure quality check of inspection documents for single case outputs
•Ensure performance metrics are generated and distributed (e.g. submission compliance, volumes, turnaround times)
•Provide subject matter expertise in the interpretation of regulations as it relates to case processing
•Audit/inspection response SME for case related findings
Knowledge and Skills
•Knowledge of global regulatory requirements for pharmacovigilance
•Extensive people management experience
•Expertise in all aspects of case management
•Experience in managing vendor relationships

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

Education & Experience (Preferred)
•Experience interacting with regulators during inspections
•Organizational expert within defined subject area
•Applies expert knowledge and broad understanding of multiple disciplines
•Knowledge of FDA, EMEA, and other international regulations for pharmacovigilance
•Collaboration and leadership skills
•People management
•Business change implementation
•Proficiency in technical safety systems
•Presentation and communication skills
•Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook
•Knowledge of communications tools and processes
•Knowledge of continuous improvement methodologies
•Understands impact of emerging scientific/technical trends and their implications for Client
•Create insightful and progressive functional strategy (multi-year)
•Manage individual and group projects of moderate complexity
•Vendor management experience
•Strong communication, interpersonal, and leadership skills

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