- 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.
- Establish and refine key performance indicators to ensure overall quality and compliance with associated with GPS Safety Science deliverables.
- Liaise with GPS subject matter experts, Regulatory Affairs, Medical Affairs and other key functions on key performance indicators and proactively identify potential trends or significant non-compliance.
- 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.
- 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.
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Regeneron Pharmaceuticals, Inc Dublin, Ireland Full timeThis position is responsible for supporting the quality & compliance activities associated with Global Patient Safety. Such activities include, but are not limited to, ensuring GPS inspection readiness, leading GPS facilitation for all GPS-impacted audits and inspections, and sup ...
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Regeneron Pharmaceuticals, Inc Dublin, Ireland Full timeWe are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient saf ...
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Assoc Dir GPS Quality - Dublin, Ireland - Regeneron Pharmaceuticals, Inc
Description
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:
Job Requirements:
