Job Description

General Description:
This contract position is responsible for supporting the Global Patient Safety (GPS) Quality Management System through the development, revision, and maintenance of safety procedural documentation and the Pharmacovigilance System Master File (PSMF). The role ensures that all documentation and standards are compliant with applicable global regulatory requirements. The individual will operate within the GPS Quality Management Operations (QMO) group, contributing to the achievement of QMO objectives and functional goals.

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  Support GPS procedural document management activities including the creation, review, and revisions of controlled documents, policies and procedures and the GPS PSMF process.
  
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  Support the maintenance of the Global PSMF, local PSMFs and annexes on a regular basis to ensure that content accurately reflects BeiGene PV processes and compliance with regulatory requirements in an expedited manner.
  
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  Ensures high service level to GPS stakeholders by advising on both PSMF and document strategy for GPS teams and supports content development for the PSMF and specific procedures across multidisciplined teams.
  

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  Leads procedural document development across the multidisciplined teams and ensure adequate input from cross-functional GPS groups and external business functions.
  
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  Actively ensures collaboration with GPS management, subject matter experts and other functions to develop or revise SOPs and procedural documents and ensures adequate input from business functions.
  
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  Identifies, supports to actively resolve and escalate procedural document-related issues.
  
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  Leads in global harmonization of procedural documents to ensure clarity of content, consistency in application of BeiGene documentation hierarchy and its conventions.
  

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  Support the end-to-end management of Global and/or Local PSMFs, including data collection, timely receipt of data and supporting documentation for quality control, Veeva workflow management, query resolution and follow-up, logbook generation, and PSMF formatting and publishing.
  
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  Responsible for reviewing PSMF data and ensuring the application of internal core PSMF strategy, to ensure correct data inclusion
  
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  Responsible for conducting timely quality control checks for each PSMF contribution, including but not limited to PSMF Narrow Reviews and PSMF Consistency Checks for Global and Local PSMF.
  
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  Participating and supporting in Audits and Inspections as a PSMF SME.
  
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  Maintains oversight of local PSMFs and variations and deviation to the Core PSMF due to local regulations.
  

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  Five years or more of experience in pharmacovigilance in operational roles, has a deep understanding of pharmacovigilance and regulatory requirements & processes.
  
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  Minimum three years of experience of PV quality management, standards and PSMF maintenance.
  
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  Demonstrated experience with implementing cross-functional partnerships and business processes.
  
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  Strong command of global pharmacovigilance requirements.
  
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  Proficient in Veeva Quality
  

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  Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience
  
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  Advanced Life Sciences Degree a plus
  

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