Aditi Consulting · 4 hours ago
Manager Case Management
United States
Full-time
Remote
Mid, Senior Level
4+ years exp
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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 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
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
Qualification
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Required
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
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
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred
PV & Global regulations
Managing business partner relationships
Strong communication skills
Ability to work independently
Company
Aditi Consulting
Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.
1,001-5,000 employees
H1B Sponsorship
Aditi Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (24)
2022 (22)
2021 (27)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Raja Narayana
President & CEO
Pradeep Singh
Chairman
Recent News
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