QPPV Office (QPO) Specialist - Remote

Overview

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

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. Contributes to the Customer’s full Pharmacovigilance and Quality system or parts of it, and  timely processes, reports and exchanges  safety information for medicinal products of Biomapas contractual partners with Competent Authorities and respective partners, while utilizes and supports domestic, EU and partners technological systems and databases.

In Short

• Contribute to the Customer’s full Pharmacovigilance and Quality system or parts of it.
• Perform intake, data entry, quality check control, documentation, reporting/exchange and other process steps for safety reports.
• Support maintenance, updating and validation of the global Safety Database.
• Ensure weekly monitoring of international literature review.
• Ensure reconciliation process of identified safety information with Biomapas partners.
• Deliver pharmacovigilance trainings to personnel when required.
• Supervise local handling of Periodic Safety Update Reports and Risk Management Plans.
• Ensure continuous safety profile monitoring and evaluation.
• Participate in related inspections and audits.

Requirements

• Experience in Pharmacovigilance or related field.
• Knowledge of regulatory requirements and Quality Management Systems.
• Strong data entry and documentation skills.
• Ability to perform quality checks and ensure compliance.
• Excellent communication and training skills.
• Ability to work collaboratively with partners.

Benefits

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