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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.