Sr. QPPV Office (QPO) Specialist

Biomapas; España; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading global pharmacovigilance organization is seeking a Sr. QPPV Office (QPO) Specialist to manage full pharmacovigilance systems and ensure compliance with relevant regulations. The ideal candidate has a degree in Life Sciences and at least 4 years of experience in pharmacovigilance. This role offers professional growth, a supportive work environment, and the chance to work remotely within the EU.

Servicios

Professional growth and career opportunities

Supportive work environment

Bonus system

Additional health insurance

International team

Formación

• At least 4 years of experience in pharmacovigilance roles.
• Experience in regional QPPV role and risk minimization activities will be considered as an asset.
• Strong computer literacy with intensive experience with safety databases.

Responsabilidades

• Manage full Pharmacovigilance systems and projects.
• Ensure oversight of the contractual partner safety data exchange agreements.
• Communication with Competent Authorities.

Conocimientos

Fluent English language

Attention to detail

Problem-solving skills

Time-management

Educación

University degree in Life Science field

Herramientas

Safety databases

MS Office

Descripción del empleo

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

Sr. QPPV Office (QPO) Specialist is responsible for the development of pharmacovigilance systems, and the oversight of end-to-end pharmacovigilance activities and projects’ compliance with Quality Management System as well as the reporting and exchanging of safety and pharmacovigilance information for medicinal products.

Position is in any EU country.

Responsibilities:

• Manage full Pharmacovigilance systems and projects (or part of them)
• Promote, maintain, improve compliance with Pharmacovigilance (PV) tasks and responsibilities
• May act as Regional QPPV or deputy
• Influence the performance of the quality system and PV activities
• Develop, update, and review standard operating procedures for global pharmacovigilance processes, and implement changes to fulfill requirements
• Supervise, prepare and submit PSURs, Risk Management Plans and risk minimization activities
• Be the primary point of contact for PV-related matter Ensure oversight of the contractual partner safety data exchange agreements
• Ensure the survey and monitoring of European (including UK) level pharmacovigilance regulations
• Provide Pharmacovigilance trainings
• Ensure continuous safety profile monitoring, detection of new signals and evaluation
• Communication with Competent Authorities
• Participate in related inspection and/or audits

• University degree in Life Science field
• At least 4 years of experience in pharmacovigilance roles, including in-depth, demonstrated experience in most areas pertaining to pharmacovigilance, and expert knowledge of pharmacovigilance legislation
• Experience in regional QPPV role and risk minimization activities will be considered as an asset
• Experience in Pharmacovigilance Medical writing
• Strong computer literacy with intensive experience with safety databases
• Ability to interpret and apply global drug safety regulations
• Fluent English language
• Good knowledge of medical terminology
• Attention to detail, time-management and problem-solving skills
• Proficient knowledge in MS Office

• Professional growth and career opportunities
• Supportive work environment
• Additional benefits (bonus system, additional health insurance and etc.)
• International team
• Remote work