[ZLO016] Drug Safety Officer

Asphalion; Barcelona; Presencial; EUR 40.000 - 55.000; Jornada completa

Descripción de la vacante

Asphalion busca un Drug Safety Officer para unirse a su equipo, donde podrás impactar en la seguridad de los medicamentos a nivel global. Este rol implica diversas responsabilidades en farmacovigilancia, ofreciendo un contrato permanente, un horario flexible y oportunidades de desarrollo profesional. Con más de 2 años de experiencia, fluidez en inglés y español, y un enfoque en el trabajo en equipo y la comunicación detallada, eres el candidato ideal para este emocionante desafío.

Servicios

Contrato permanente

Horario flexible

Modelo de trabajo híbrido o remoto

Programas de capacitación y desarrollo personal

Clases de inglés

Formación

• Más de 2 años de experiencia en departamentos de farmacovigilancia.
• Fluidez en inglés y español.
• Proactivo y orientado a resultados.

Responsabilidades

• Realizar evaluaciones de literatura global/local cada semana.
• Gestionar informes de seguridad individual y eventos adversos.
• Preparar y revisar informes de solicitud de medicamentos (PSURs, RMPs).

Conocimientos

Comunicación

Orientación a detalles

Trabajo en equipo

Educación

Licenciatura en Ciencias de la Vida y Farmacovigilancia

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.

If you’re passionate about ensuring drug safety and eager to grow professionally, join us at Asphalion and be part of a team at the forefront of pharmacovigilance innovation!

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.

El anuncio original lo puedes encontrar en Kit Empleo:
https://www.kitempleo.es/empleo/210437268/zlo016-drug-safety-officer-barcelona/?utm_source=html