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Patient Safety Attendant Jobs
Recruited by MaineHealth 11 months ago Address Farmington, ME, United States

Global Patient Safety Quality Management Lead

Company

Argenx
Address , Boston, Ma
Employment type FULL_TIME
Salary
Expires 2023-07-16
Posted at 11 months ago
Job Description
PURPOSE OF THE FUNCTION
The Global Patient Safety (GPS) Quality Management Lead is responsible for the operational implementation of the Pharmacovigilance Quality Management System (QMS) in a consistent, effective and efficient way within the Global Patient Safety functional area.
  • Manage GPS Procedural Document activities Management activities
  • Drive the growth of the GPS Quality Management function
  • Lead & actively participate in GPS Audit & Inspection Readiness, Support & Management together with other GPS QM team members
  • Contribute to Management Commitment by Communicating the GPS “state of health” and escalating issues to GPS management (e.g., Key Performance Indicator status and compliance, quality, or training risks)
  • This position will also:
  • Drive & Implement the Comprehensive Training Program
  • Drive GPS Continuous Improvement (Issue Management, Process improvement, KPI development)
ROLES AND RESPONSIBILITIES
Drive & Implement Comprehensive Training Program:
  • Develop, maintain and deliver an effective and comprehensive pharmacovigilance training program
  • Identify additional pharmacovigilance training needs, prepare and conduct training as applicable together with GPS QM team members
  • Support other GPS QM team members in monitoring, maintaining, re-evaluating and updating the GPS training curricula
  • Advance, expand, and communicate the current pharmacovigilance training (onboarding training, refresher training, inspection readiness training, GPS portal enhancement organizational central training {e.g., argenx training academy} routine procedural document training)
  • Work closely with key stakeholders to support and/or implement pharmacovigilance training across the company globally and to expand to external partners as applicable
Manage GPS Procedural Document activities:
  • Support document control through use of Veeva System
  • Together with the GPS QM team members, manage GPS Procedural Document activities including contributing, developing, reviewing, and continually improving GPS process & procedures.
  • Monitor the status of and compliance with GPS Standard Operating Procedures (SOPs) and other controlled documents.
  • Proactively involved in cross functional Procedural Document activities/forums to determine relevance to GPS and assure appropriate GPS input and review are provided
  • Perform impact analysis for pharmacovigilance processes and compliance strategies
  • Assure appropriate change control is applied
Lead & actively participate in GPS Audit & Inspection Readiness, Support & Management
  • Identify internal deviations and lead GPS team in determining corrective and preventive actions (where appropriate)
  • Contribute to development & subsequent evaluation of Key Performance Indicators, and adapt them to reflect the evolving business needs.
  • In collaboration with QA, lead the implementation of corrective or preventive actions as appropriate
  • Assess GPS issue management trends and implement actions plans to mitigate systemic causes
  • Represents GPS in cross-functional forums, committees, and initiatives
  • Advise & lead the coordination and preparation of GPS responses to audit &inspection findings.
  • Drive GPS Continuous Improvement (Issue Management, Process improvement, KPI development)
  • Prepares GPS team members on inspection readiness activities
  • Regularly liaise with the QA Department regarding GPS quality and compliance requirements and deliverables.
  • Leads the activities to 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)
  • Represent GPS in internal audits and regulatory inspections together with other GPS team members
  • Lead global GPS audit and inspection readiness activities in collaboration with QA department
  • Direct/guide the GPS team to determine root cause of issue to avoid recurrence
  • Support the development of and monitor compliance with pharmacovigilance agreements (PVAs), Safety Data Exchange Agreements (SDEAs) and other agreements as applicable with business partners
Contribute to Management Commitment by Communicating the GPS “state of health”
  • Communicate and/or escalate issues to GPS management as appropriate (e.g., Key Performance Indicator status and compliance, quality, or training risks)
  • Prepares and presents data regarding the “State of Health” of the PV Quality System at the quarterly Quality Management Review Meetings.
SKILLS AND COMPETENCIES
  • Solution oriented with ability to prioritize and work independently
  • Demonstrated ability to author and contribute to complex documents
  • Relevant computer skills, including proficiency with Microsoft Office Suite
  • Ability to work in global environment
  • Excellent planning and organizational skills
  • Excellent presentation skills with the ability to communicate complex issues clearly
  • Ability to motivate, influence, and collaborate with multidisciplinary teams
  • Excellent oral and written communication skills
EDUCATION, EXPERIENCE AND QUALIFICATIONS
  • Excellent knowledge of drug development process, GXP quality and compliance requirements, pharmacovigilance regulatory requirements and GVP guidance documents
  • Or technical field (Master’s degree or PharmD is a plus)
  • Experience in GVP audit/inspection activities/process
  • At least 8 years of experience in the pharmaceutical/biotech industry with at least 5
  • Years in pharmacovigilance/drug safety
  • Bachelor’s or Master’s degree in pharmacy, nursing, healthcare or other life-science
  • Experience in training-related field
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