About this role
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description
1PURPOSE OF THE FUNCTION
• The Global Patient Safety (GPS) Quality Management Manager is responsible for the operational execution of the Pharmacovigilance (PV) Quality Management System (QMS) in a consistent, effective and efficient way within the Global Patient Safety functional area. • This position will also: • Contribute to driving the growth of the GPS Quality Management function. • Maintain & execute the Comprehensive Training Program. • Manage GPS Procedural Document activities • Participate in GPS Audit & Inspection Readiness, Support & Management. • Contribute to GPS Continuous Improvement (Issue Management, Process improvement, KPI development).
2REPORTING LINE
• Associate Director, GPS Quality Management or above 3ROLES AND RESPONSIBILITIES GPV internal Audit program and Inspection activities:
• Support, and/or manage GVP Audit & Inspection activities • Support internal global GVP audit program and inspection readiness activities in collaboration with the client Quality functional area. • Prepare GPS team members on inspection readiness activities. • Ensure appropriate documents are readily retrievable to use during an Inspection (GPS inspection slides, CVs, JDs, PVAs are contact information is updated and readily available). • Support the coordination and preparation of GPS responses to audit &inspection findings.
Deviation & Corrective and Preventive Action (CAPA) activities:
• Assess GPS issue management trends and implement actions plans to mitigate systemic causes. • Identify internal deviations and support / advise GPS team in determining corrective and preventive actions. • Support/guide the GPS team to determine root cause of issue to avoid recurrence. • In collaboration with the client Quality functional area, lead the implementation of corrective or preventive actions.
Training, Procedural Document, & Record Management activities:
• Contribute to the development of the Pharmacovigilance training program. • Maintain, expand, and deliver the pharmacovigilance training program (procedural documents, inspection readiness, refresher training, etc). • Work closely with key stakeholders to support and/or implement pharmacovigilance training across the organization. • Support the monitoring, maintaining, re-evaluating and updating the GPS training curricula • Provide training to relevant client employees and 3rd parties (when applicable) • Manage GPS Procedural Document activities including contributing, developing, reviewing, and continually improving GPS process & procedures.
• Participate in cross functional Procedural Document activities/forums to determine relevance to GPS and assure appropriate GPS input and review are provided. • Support document control through use of Veeva System.
GPS Performance & Compliance activities
• Contribute to development & subsequent evaluation of Key Performance Indicators and adapt them to reflect the evolving business needs. • Support monitoring of compliance to 3rd party contractual obligations/PVAs and determine if there are gaps or non-conformities and report appropriately into GPS staff • Liaise with the QA Department regarding GPS quality & compliance requirements/deliverables. • Support monitoring the status of and compliance with GPS Standard Operating Procedures (SOPs) and other controlled documents. • Support the compliance monitoring of the pharmacovigilance agreements (PVAs), Safety Data Exchange Agreements (SDEAs) and other agreements as applicable with business partners
Other Activities:
• Perform other tasks and duties as assigned by line manager or GPS Leadership 4SKILLS AND COMPETENCIES
• Excellent planning and organizational skills. • Excellent oral and written communication skills. • Ability to work in global environment. • Solution oriented with ability to prioritize and work independently. • Robust presentation skills with the ability to communicate complex issues clearly. • Demonstrated ability to author and contribute to procedural documents. • Ability to motivate and collaborate with multidisciplinary teams. • Relevant computer skills, including proficiency with Microsoft Office and tracking databases. • Fluency in written and spoken English.
5EDUCATION, EXPERIENCE AND QUALIFICATIONS
• At least Bachelor’s degree in pharmacy, nursing, healthcare or other life-science or technical field or country equivalent combination of education and experience • At least 5 years of experience in the pharmaceutical/biotech industry with at least 3 years in relevant pharmacovigilance/drug safety field • Good track record of operating pharmacovigilance quality systems, processes and teams • Experience with preparing for, hosting and responding to audits and regulatory inspections globally • Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan) • Knowledge of GXP quality and compliance requirements, processes and measures.