Sr. QPPV Office (QPO) Specialist
BiomapasConnecticut, United States
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 Sr. QPPV Office (QPO) Specialist is responsible for developing pharmacovigilance systems, overseeing end-to-end activities, and ensuring compliance with Quality Management System regulations. The position involves promoting compliance, supervising PSURs, and ensuring contractual partner safety data exchange. This role supports the ongoing monitoring of European (including UK) pharmacovigilance regulations.
Requirements
- Manage full Pharmacovigilance systems and projects
- Promote, maintain, and improve Pharmacovigilance (PV) compliance
- Supervise, prepare PSURs, Risk Management Plans, and risk minimization activities
- Ensure continuous safety profile monitoring, detection of new signals, and evaluation
- Provide Pharmacovigilance trainings
- Ensure contractual partner safety data exchange agreements
- Ensure surveys and monitoring of regulatory requirements
- Communication with Competent Authorities
- Participate in inspections and audits
Benefits
- Professional growth and career opportunities
- International team and environment
- Bonus based on annual performance
- Personal accident and business trip insurance
- Influenza vaccines
- Rewarding referral policy
- Workplace establishment allowance
- Flexible working hours
- Team building, global meetings, B active events