QPO (QPPV office) Specialist
BiomapasMasovian Voivodeship, Poland • Capital City of Prague, Prague, Czechia • Poland • Masovian Voivodeship, Poland • Masovian Voivodeship, Poland
Posted September 26, 2025
Full Time
About the Company
Biomapas is a functional and full outsourcing solution provider to the global life science industry. As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle. Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success. We keep our promises. Always. Social media privacy policy: bit.ly/privacy-biomapas
Job Description
The QPO Office (QPV) Specialist is a vital part of the global Pharmacovigilance team, ensuring regulatory compliance, Quality Management Systems, and smooth process operation. This role involves supporting the pharmacist and pharmacist-driven Pharmacovigilance department with data entry, reporting, and compliance, while contributing to Pharmacovigilance and Quality system development. The position supports full Pharmacovigilance and Quality system parts, and the completion of relevant Safety reports.
Requirements
- Contribute to the Customer’s full Pharmacovigilance and Quality system
- Develop/maintain/document/submit PSMFs, SOPs, Periodic Aggregate Safety reports, Database operations
- Support with maintenance/updating/validation of the Safety Database
- Perform data entry, quality check control, documentation, reporting/exchange
- Support with processes of maintenance/updating/validation of the Safety Database
- Ensure weekly monitoring of international literature review
- Ensure reconciliation process for identified safety information
- Deliver pharmacovigilance trainings
- Supervision of local handling of Safety reports and risk management plans
- Ensure continuous safety profile monitoring
- Participate in related inspections and/or audits
- Medical Information experience preferred
Benefits
- Professional growth and career opportunities
- International team and environment
- Bonus based on annual performance
- Personal accident and business trip insurance
- Additional health insurance
- Remote/home based work
- Influenza vaccines
- Rewarding referral policy
- Workplace establishment allowance