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Assoc Dir Gps Quality
3 months ago
Summary:
This position is responsible for supporting the quality & compliance activities associated with Global Patient Safety (GPS).
Such activities include developing, performing, trending and analyzing quality and compliance metrics and associated outputs related to Safety Sciences Quality & Compliance deliverables.
This role will be reporting into the head of GPS Quality and Compliance (Q&C) and requires people management.Job Duties:
Develop and execute a compliance and quality oversight governance for GPS Safety Sciences deliverables including, but not limited to, Risk Management Plans, Signal Management, and the Pharmacovigilance System Master File.
Conduct Global Patient Safety-related non-compliance investigations for minor events including trending and support investigation and CAPA implementation of any significant quality events based on established documented procedures associated with benefit-risk deliverables.
Provide support, for quality review of additional GPS deliverables, including but not limited to, Safety Agreements and Safety Management Plans.
Support GPS-related audits and inspections.As needed, assist in review and contribution to Global Patient Safety Quality and Compliance-related documented procedures.
Effectively manage workload to independently ensure overall compliance with standards and timelines.
Work effectively with other Global Patient Safety sub-functions, Contract Research Organization, Vendors, and relevant personnel to discuss issues and identify timely solutions.
Participate in the continuous process improvement effort within the function to identify gaps and advise management accordingly.Responsible for management of assigned Quality & Compliance staff as applicable; this includes but is not limited to management of job performance, career development and training.
Job Requirements:
Good communication skills, both written and verbal.
Ability to multi-task and effectively manage demanding timelines.
Ability to work collaboratively across functions and roles.
High level of accountability; drive results.
Strong 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).
Knowledge of medical concepts and terminology.
Familiarity with data analytics platforms.
Strong knowledge of safety database.
Expertise in benefit-risk management.
Bachelor's Degree, minimum 10-years pharmacovigilance-related experience, healthcare professional preferred.
