Global Pharmacovigilance Coordinator

hace 5 días


Santiago, Metropolitana, Chile Allergan A tiempo completo

About the Job Description:

This role executes day-to-day operations and compliance activities to maintain PV systems. Reports to PV Operational Team Lead or Regional PV Lead.

Main Tasks:

  • Develop and implement metrics for PV system performance and functionality in compliance with regulations and internal timelines.
  • Maintain local and regional procedures aligned with corporate procedures and local requirements.
  • Assess the impact of new or updated corporate policies, processes, and procedures.
  • Support the PV Exception Reporting/CAPA process.
  • Contribute to business continuity planning and testing.
  • Develop and maintain local PSFs in line with AbbVie's PV system master file, as required by local and regional regulations.
  • Analyze and translate adverse event information from various sources.
  • Perform ICSR expedited reporting in accordance with local requirements.
  • Ensure local-language medical and scientific literature review.
  • Implement local quality control procedures to ensure reporting quality.
  • Complete AE reconciliation and verify AE identification effectiveness sampling consistency with global procedures.
  • Prepare periodic safety reports, local annexes, and translation of safety deliverables.
  • Submit periodic safety reports and document evidence.
  • Support internal PV audits, audits of third-party services, and regulatory authority inspections.
  • Develop CAPAs in response to observations and track actions to completion in a timely manner.
  • Ensure all PV requirements are met for activities involving safety information handling.
  • Maintain training compliance with corporate and local PV procedures.
  • Monitor local PV-relevant hard intelligence and lead impact assessments.
  • Review and evaluate incoming local safety data and communicate findings to stakeholders.
  • Ensure 24-hour availability and establish an after-hours process for AE reporting and a disaster recovery plan/business continuity plan for critical PV processes.
  • Minimum 2 years of experience in pharmacovigilance or a related field.
  • Effective communication and teamwork skills.
  • Commitment to compliance with relevant rules and procedures.
  • Effective planning, organization, and quality delivery skills.


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