Drug Safety Officer

JR Spain; Valencia; A distancia; EUR 10.000 - 30.000; Jornada completa

Descripción de la vacante

A pharmaceutical company based in Spain is seeking a Drug Safety Officer to join their team. The ideal candidate will manage pharmacovigilance reports, stay updated on regulations, and provide expert medical advice. This role offers flexibility with remote or hybrid working options and a commitment to professional development in a diverse environment.

Servicios

Homeoffice & Hybrid or Remote Model

Training and personal development program

Focus on employee well-being

Formación

• Over 2 years of experience in Pharmacovigilance departments.
• Proactive and good communication skills are essential.
• Detail-oriented and capable of working in a team.

Responsabilidades

• Perform weekly global/local literature assessments.
• Manage Individual Case Safety Reports (ICSRs) efficiently.
• Ensure compliance with updated pharmacovigilance regulations.

Conocimientos

Pharmacovigilance

Communication

Attention to detail

Teamwork

Educación

Academic Degree in Life Science and Pharmacovigilance

Herramientas

MS Office

Descripción del empleo

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¡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.

Advanced IT level – (MS Office)

Academic Degree in Life Science and Pharmacovigilance.

Proactive, good communication, accurate, detail orientated, teamwork

Why working at Asphalion?

? 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.

? 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.