Drug Safety Officer

ASPHALION; Bilbao; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading pharmacovigilance company in Bilbao is seeking a Drug Safety Officer to ensure drug safety through managing case reports and liaising with regulatory authorities. The ideal candidate should have at least 2 years of experience in pharmacovigilance, be fluent in English and Spanish, and possess strong IT skills. This position offers a flexible working schedule with a hybrid work model.

Servicios

Permanent contract

Flexible working schedule

Homeoffice & Hybrid or Remote

Training and personal development program

English lessons

Well-being programme

Internal activities & RSC Activities

Formación

• Minimum 2 years experience in Pharmacovigilance departments.
• C1 level fluency in English and Spanish required.
• Advanced proficiency in MS Office necessary.

Responsabilidades

• Conduct global/local literature assessments weekly.
• Manage Individual Case Safety Reports (ICSRs).
• Report to European authorities via EudraVigilance.
• Liaise with Spanish Regulatory Authorities for pharmacovigilance.

Conocimientos

Experience in Pharmacovigilance

Fluent in English

Fluent in Spanish

Advanced IT skills

Proactive communication

Attention to detail

Teamwork

Educación

Degree in Life Science

Pharmacovigilance certification

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 (C1) & Spanish.
• Advanced IT level – (MS Office).
• Academic Degree in Life Science and Pharmacovigilance.
• Proactive, good communication, accurate, detail oriented, 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.