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
- 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
- Influenza vaccines
- Rewarding referral policy
- Workplace establishment allowance (fully remote)
- Team building, global meetings, B active events
Top Skills
What We Do
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.
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