Drug Safety Officer

ASPHALION; España; Híbrido; EUR 10.000 - 30.000; Jornada completa

Descripción de la vacante

A leading drug safety company in Spain seeks a Drug Safety Officer to conduct literature assessments and manage safety reports. Candidates should be fluent in English and Spanish and have at least 2 years of experience in Pharmacovigilance. This position offers a flexible working schedule with options for hybrid or remote work, focusing on personal development and well-being.

Servicios

Permanent contract

Flexible working schedule

Homeoffice & Hybrid model

Training and personal development program

English lessons

Formación

• Minimum of 2 years experience in Pharmacovigilance departments.
• Strong IT skills required, particularly in MS Office.
• Ability to communicate effectively in both English and Spanish.

Responsabilidades

• Perform weekly global/local literature assessments.
• Manage Individual Case Safety Reports (ICSRs) and Adverse Events (AEs).
• Provide support to local and EU Qualified Persons for Pharmacovigilance.

Conocimientos

Fluent in English

Fluent in Spanish

Proactive

Good communication

Detail oriented

Teamwork

Educación

Academic Degree in Life Science and Pharmacovigilance

Herramientas

MS Office

Descripción del empleo

Overview

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 & 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.

A professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.

A highly & dynamic working environment with employees from more than 15 nationalities.

Our people and their well-being are our priority : Physical, psychological and emotional well-being programme.

Internal activities & RSC Activities