QPPV Office Specialist - Remote

Overview

Join our global Pharmacovigilance team as a QPPV Office (QPO) Specialist.

The QPPV Office (QPO) Specialist supports the QPPV Office and Pharmacovigilance (PV) department by ensuring compliance with regulatory requirements, Quality Management Systems, and maintaining smooth operation of pharmacovigilance processes.

In Short

• Contribute to the Customer’s full Pharmacovigilance and Quality system.
• Perform intake, data entry, quality check control, documentation, reporting/exchange for safety reports.
• Support maintenance, updating, and validation of the global Safety Database.
• Ensure weekly monitoring of international literature review.
• Manage reconciliation process of identified safety information with partners.
• Deliver pharmacovigilance trainings to personnel when required.
• Supervise local handling of Periodic Safety Update Reports and Risk Management Plans.
• Monitor safety profiles and detect new signals.
• Participate in inspections and audits, providing support as needed.

Requirements

• Experience in Pharmacovigilance or related field.
• Knowledge of regulatory requirements and Quality Management Systems.
• Strong data entry and quality control skills.
• Ability to manage and validate databases.
• Excellent communication and training skills.
• Strong attention to detail and organizational skills.

Benefits

• Opportunity to work in a global team.
• Engagement in meaningful work in the healthcare sector.
• Professional development opportunities.