Junior QPPV Office (QPO) Specialist

Biomapas; Strasbourg; Hybride; EUR 30 000 - 45 000; Plein temps

Résumé du poste

A leading international pharmacovigilance firm is seeking a Junior QPPV Office Specialist to support the QPPV Office and ensure compliance with regulatory requirements. This role involves contributing to pharmacovigilance processes, performing data management, and delivering trainings. Candidates should have a relevant university degree, at least 1 year of experience in pharmacovigilance, and strong attention to detail. The position offers remote working and a variety of professional development opportunities.

Prestations

Professional growth and career opportunities

International team and environment

Bonus based on annual performance

Personal accident and business trip insurance

Additional health insurance

Complimentary health and wellness benefits

Rewarding referral policy

Workplace establishment allowance

Team building events

Qualifications

• At least 1-year experience in Pharmacovigilance and expert knowledge of pharmacovigilance legislation.
• Knowledge of international regulations like ICH, EU GVP Modules, FDA.
• Eager to adopt automations and new technologies in daily tasks.

Responsabilités

• Contribute to the Customer’s Pharmacovigilance and Quality system.
• Perform intake, data entry, quality check control for safety reports.
• Support maintenance and validation of the global Safety Database.
• Deliver pharmacovigilance training when required.
• Participate in related inspections and audits.

Connaissances

Pharmacovigilance

Strong computer literacy

Attention to detail

Time-management

Problem-solving skills

Fluent English

Formation

University degree in the Life Science field

Outils

PV databases

Description du poste

Join our global Pharmacovigilance team as a Junior QPPV Office (QPO) Specialist.

Junior 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. All CVs must be submitted in 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

Qualifications:

• 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)
• Experience working with PV databases is preferable
• 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

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