ProPharma

QA Engineer

• Serve as a key subject matter expert in assigned areas of quality assurance and regulatory/GxP
• Provide independent consultation and project leadership across CQA projects
• Lead and manage client MIA/WDA projects and PPG MIA license activities, including QP batch certification, GxP auditing, and QMS development
• Ensure successful execution and profitability of key projects
• Monitor regulatory and technological changes in the CQA field
• Contribute to risk-based and phase-appropriate GxP projects
• Act as SME in commercial processes and identify scope and effort required for client needs
• Promote CQA services across the industry
• Promote continual improvement in customer satisfaction
• Provide CQA-specific training to clients and associates
• Support clients and ProPharma functional units with GxP issues, including deviations and non-conformances
• Consult on CAPA implementation and support compliance with quality principles
• Participate in quality-system development through SOP writing and training
• Educate employees at all levels on compliance and quality assurance
• Perform the Qualified Person or Responsible Person function for clients, as applicable
• Perform other duties as assigned

Senior Compliance and Quality Assurance Consultant

Compliance

• Manage and monitor expedited and non-expedited Individual Case Safety Report (ICSR) submissions and exchanges
• Ensure compliance with global pharmacovigilance reporting requirements and internal procedures
• Conduct monthly ICSR reconciliation activities with clients and safety partners
• Support gateway-to-gateway testing for health authority submissions and safety partner exchanges
• Assist with investigation, documentation, and resolution of submission-related deviations and CAPAs
• Generate Argus-based line listings and summary tabulations for periodic safety reports
• Assist in creating, validating, and quality reviewing custom reports and reporting outputs
• Support setup, verification, and maintenance of periodic reporting requirements across global markets
• Coordinate periodic report submissions in compliance with local regulatory requirements
• Support pharmacovigilance reporting services and operational excellence
• Research, collect, and maintain global pharmacovigilance reporting requirements
• Conduct monthly regulatory surveillance and impact assessments
• Support regulatory intelligence tools, mailboxes, tickets, queries, and ad hoc projects
• Provide guidance on evolving pharmacovigilance regulations and reporting obligations
• Perform Performance Qualification (PQ) testing for Argus upgrades, patches, and custom developments
• Support implementation and validation of territory-specific and custom E2B profiles
• Participate in data migration testing and submissions-related system enhancements
• Contribute to projects improving efficiency, quality, and system performance
• Prepare and maintain xEVMPD submissions, updates, removals, and new product entries
• Conduct peer review and quality control of xEVMPD submissions
• Support bulk updates, QPPV changes, master file location updates, and developmental product registrations

Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions

General

• Adhere to pharmacovigilance regulatory reporting processes and instructions
• Monitor scheduled expedited and non-expedited ICSR submissions and exchanges daily
• Execute monthly ICSR reconciliation reports with PV clients and safety partners
• Assist in testing gateway-to-gateway submissions to health authorities and ICSR exchanges
• Create and close submissions-related deviations and associated CAPAs
• Generate Argus-based line listings and summary tabulations for Periodic Safety Reports
• Assist with generating and verifying custom periodic reporting
• Assist with setup and verification of Periodic Safety Report requirements
• Coordinate, develop, and maintain pharmacovigilance reporting services with the management team
• Perform PQ testing for multi-tenant Argus upgrades, patches, custom projects, and data migration imports
• Execute process and documentation updates for territory-specific and custom E2B profiles

Pharmacovigilance Specialist, Submission

Risk

• Support day-to-day pharmacovigilance and benefit-risk activities across assigned projects
• Enter and maintain project-related information within internal systems
• Assist with local literature screening and associated operational activities
• Support training of affiliate personnel on relevant pharmacovigilance responsibilities
• Coordinate meetings, prepare agendas, and distribute meeting documentation
• Record and maintain pharmacovigilance meeting minutes and action logs
• Manage filing, archiving, and document control activities
• Provide administrative support to the Pharmacovigilance department and project teams
• Assist with preparation and coordination during audits and inspections
• Ensure activities comply with company procedures, quality standards, and client requirements
• Contribute to continuous improvement initiatives and other duties as required

Senior Compliance and Quality Assurance Consultant

Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions

Pharmacovigilance Specialist, Submission

Pharmacovigilance Coordinator, Benefit Risk