Pharmacovigilance Safety officer

ASPHALION; Madrid; Híbrido; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading drug safety company in Madrid seeks a Drug Safety Officer to manage pharmacovigilance tasks. The role requires 2 years of experience, fluency in both English and Spanish, and IT proficiency. Offering a flexible working schedule and remote options available throughout Spain, this position supports various projects in drug safety management.

Servicios

Permanent contract

Flexible working schedule - Friday until 15.30h

Homeoffice & Hybrid or Remote Model

Training and personal development program

English lessons

Formación

• Minimum 2 years of experience in Pharmacovigilance departments.
• Advanced IT skills required.
• Ability to work accurately and in a detail-oriented manner.

Responsabilidades

• Perform weekly global/local literature assessments.
• Manage Individual Case Safety Reports (ICSRs) and Adverse Events (AEs).
• Report to European authorities via EudraVigilance.
• Liaise with Spanish Regulatory Authorities.

Conocimientos

Fluency in English (C1)

Fluency in Spanish

Proactive communication

Attention to detail

Educación

Academic Degree in Life Science and Pharmacovigilance

Herramientas

MS Office

Descripción del empleo

¡Be part of the future of drug safety at Asphalion! We’re looking for a

Drug Safety Officer

ready to embrace new challenges in a fast-moving, international environment. If you thrive on precision and want to make a real impact, we’d love to have you on our team!

Key Responsibilities

• Perform weekly global / local literature assessments.
• Efficiently manage Individual Case Safety Reports (ICSRs), Adverse Events (AEs), and follow-up activities.
• Manage cases through the Pharmacovigilance Database and report accurately to European authorities via EudraVigilance.
• Translate relevant pharmacovigilance information into English and liaise with Spanish Regulatory Authorities.
• Provide support to local and EU Qualified Persons for Pharmacovigilance (EUQPPv).
• Stay informed about updates in global and local pharmacovigilance regulations.
• Oversee the maintenance of the PSMF and Asphalion’s Pharmacovigilance System (SOPs).
• Prepare and review PSURs, RMPs, DSURs, and ACOs with attention to detail.
• Offer expert medical advice and support Medical Information projects.
• Draft and review Pharmacovigilance agreements and provide strategic insights.
• Prepare and conduct internal Pharmacovigilance training sessions.

Requirements

• 2 years experience in Pharmacovigilance departments.
• Fluent in English (C1) & Spanish
• Advanced IT level – (MS Office)
• Academic Degree in Life Science and Pharmacovigilance.
• Proactive, good communication, accurate, detail orientated, teamwork

Why working at Asphalion?

️Permanent contract.

Flexible working schedule - Friday until 15.30h.

Homeoffice & Hybrid or Remote Model (You can be located anywhere in Spain!)

⚙️ Wide variety of projects, new challenges and experiences.

↗️ Training and personal development program.

English lessons.