QPO (QPPV office) Specialist

Remote from: Lithuania
Annual salary: Undisclosed
Salary information is not provided for this position. Check our Salary Directory to estimate the average compensation for similar roles.
Department: Legal & Compliance
Employment type: Full Time,
Job posted: 1 Sep 2025
Apply before: 1 Oct 2025
Experience level: Senior
Views / Applies: 459 / 45

Big Enough To Cover All Your Needs. Small Enough To Care.

Pharmaceuticals
2011

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

University degree in the Life Science field
At least 2-year experience in Pharmacovigilance and expert knowledge of pharmacovigilance legislation
Knowledge of international regulations (ICH, EU GVP Modules, FDA)
Experience working with PV databases
Strong computer literacy
Ability to interpret and apply global drug safety regulations
Fluent English language
Eager to adopt automations and new technologies in daily tasks
Attention to detail, time-management and problem-solving skills
Medical Information experience preferred

Benefits