QPO (QPPV office) Specialist

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.

Position is in any EU Union country .

Responsibilities :

• Contribute to the Customer’s full Pharmacovigilance and Quality system or parts of it. The development / maintenance / documentation / submission of : PSMFs, SOPs, Periodic Aggregate Safety reports, Database operations, Contractual arrangements, PV compliance data, (additional) Risk Minimization and PV activities and Regulatory intelligence processes
• Perform intake, data entry, quality check control, documentation, reporting / exchange and other process steps as applicable for safety reports following procedures and within safety databases
• Support with the processes of maintenance, updating and validation of the global Safety Database as required, or support Biomapas partners in performing such activities
• Ensuring weekly monitoring of international literature review
• Ensuring that reconciliation process of identified safety information is in place and performed regularly with Biomapas contractual partners
• Delivering pharmacovigilance trainings to Biomapas and Biomapas contractual partners' personnel, when required
• Supervision of local handling, including preparation and submission, of Periodic Safety Update Reports, Risk Management Plans and risk minimization activities
• Ensuring continuous safety profile monitoring, detection of new signals and evaluation, as applicable
• Participating in related inspection and / or audits, including post inspection / audit support, when required

Requirements

Benefits