Junior Qppv Office Specialist

Summary

Join our global Pharmacovigilance team as a Junior QPPV Office (QPO) Specialist. This role supports the QPPV Office and Pharmacovigilance (PV) department, ensuring compliance with regulations and maintaining smooth operation of pharmacovigilance processes. You will contribute to the Customer’s full Pharmacovigilance and Quality system, processing and reporting safety information for medicinal products. The position is based in any EU country, requiring English fluency. Responsibilities include contributing to the development and maintenance of various pharmacovigilance documents and systems, performing data entry and quality checks, supporting database maintenance, and delivering training. The role requires a life science degree, pharmacovigilance experience, and knowledge of international regulations.

Requirements

• University degree in the Life Science field
• At least 1-year experience in Pharmacovigilance and expert knowledge of pharmacovigilance legislation
• Knowledge of international regulations (ICH, EU GVP Modules, FDA)
• Strong computer literacy
• Ability to interpret and apply global drug safety regulations
• Fluent English language

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
• 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

Preferred Qualifications

• Experience working with PV databases
• Eager to adopt automations and new technologies in daily tasks
• Attention to detail, time-management and problem-solving skills

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
• Complimentary health and wellness benefits, such as influenza vaccines
• Rewarding referral policy
• Workplace establishment allowance (fully remote)
• Team building, global meetings, B active events