Quality Management Associate, PV Quality Management, CSPV #: 25-08786

Job Title: Quality Management Associate, PV Quality Management, CSPV, Level II

Job Schedule: Local candidate who is able to come onsite at least once a week.

Responsibilities

This position supports the head of PV Quality Management in the delivery and oversight of global and regional PV quality management activities including Compliance and performance monitoring, Quality management, Procedural document and records management, Audit/Inspection Readiness, and Training program management in alignment with Global PV strategy. This position is responsible for administrative support including but not limited to mailbox management, scheduling meetings, documentation of meeting minutes, organizing files and records, and other administrative tasks. This position is responsible for facilitation and/or coordination of activities including but not limited to following:

• Compliance and Performance Monitoring:
  
  

Coordinates activities for the monitoring of key performance indicators (KPIs) and compliance metrics of relevant PV activities including the compilation, collation, and documentation of data including non-compliant (late) single cases and aggregate safety reporting, adherence to PV agreements, signal management activities, and other relevant global KPIs and metrics.

• Quality:
  
  

Supports activities related to issue and CAPA management for all PV processes to ensure internal processes are evaluated, summarized, and fed back for implementation of actions and process improvement.

Track implementation of corrective and preventive actions related to findings from compliance monitoring, quality issue management, audits and inspections.

• Inspection and Audit Readiness:
  
  

Supports audit/inspection readiness activities including identification of PV subject matter experts (SME) and points of contact, notification of involved PV functions, and maintenance of PV SME contact lists.

Supports the collaboration with the Global R&D/PV-QA Audit and Compliance department in preparing for internal audits and regulatory inspections, including collection, review, tracking and provision of relevant documents and other inspection/audit requests.

Facilitates and coordinates relevant activities during all phases of audits/inspections (pre-, conduct, and post-)

• Training Program Management:
  
  

Collaborates with relevant CSPV functions to support onboarding and ongoing training activities.

Works with ALTOS Administrator to assign training, generate and access necessary training reports, and ensure proper training documentation.

Supports the maintenance of the training documents and materials including role-based curriculum. May participate in creating, reviewing, and revising training documents.

• Procedural Document Management:
  
  

Support activities related to documentation control, including retirement schedules, file structures, and delivery mechanisms (ALTOS, etc.).

Supports the lifecycle management of CSPV-related policies, procedures, and operating guidelines, including but not limited to SOPs, SOIs, guidance documents, associated forms, and templates). Supports process redesign initiatives by updating relevant documentation for changes to processes.

Supports the maintenance of all documentation files, including forms and templates, and communicates updates/revisions to documents.

Experience Qualifications

• 3 or more years of Pharmacovigilance experience in a pharmaceutical, biotechnology or related environment preferred
• Possesses knowledge of Food and Drug Administration (FDA) regulations, European Union (EU) regulations, and International Conference on Harmonization (ICH) guidelines preferred
• Possesses knowledge of Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP)