Manager - Global Patient Safety Quality & Compliance
October 8
Description
• Responsible for performing quality review tasks related to ICSRs • Conduct regular quality control reviews of ICSRs • Generate and review metrics related to quality control of ICSRs • Perform regular trending of quality results to identify potential trends • Manage workload to ensure overall compliance with GPS standards and timelines • Support audits and inspections related to GPS as needed • Assist in review and contribution to GPS Quality and Compliance-related documented procedures • Participate in continuous process improvement efforts within the function
Requirements
• Minimum Bachelor's Degree with 5+ years pharmacovigilance experience • Effective and clear communication skills, both written and verbal • Ability to effectively manage demanding timelines • Ability to work collaboratively across functions and roles • High level of accountability; drive results • Understanding of global safety reporting regulations and guidelines including FDA, ICH, and GVP • Strong computer skills and experience working with the Microsoft programs (Word, Excel, PowerPoint, Outlook, Teams) • Knowledge of medical concepts and terminology • Strong knowledge of safety database (Argus preferred)
Benefits
• health and wellness programs • fitness centers • equity awards • annual bonuses • paid time off for eligible employees
Apply NowSimilar Jobs
October 8
ZEISS Group
10,000+
Support government customers as a Contracts Compliance Specialist at Zeiss.
October 8
Ensures product compliance with food safety regulations and manages customer complaints.
October 8
CluneTech
1001 - 5000
BSA/AML Compliance Officer for global payment provider TransferMate overseeing compliance programs.
October 8
Flywheel.io
51 - 200
Manage compliance programs for Flywheel's information security and healthcare audits.
October 5
COMPLY
201 - 500
Consultant providing compliance services in a high-growth regulatory tech firm.