Drug Safety Officer

ASPHALION; Las Palmas de Gran Canaria; Híbrido; EUR 35.000 - 55.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical safety firm in Spain is seeking a Drug Safety Officer to manage pharmacovigilance activities and ensure compliance with regulations. The ideal candidate has at least 2 years of experience in pharmacovigilance, is fluent in English and Spanish, and has a degree in Life Science. This position offers flexible working arrangements, including remote options, and opportunities for professional development in a dynamic work environment.

Servicios

Permanent contract

Flexible working schedule

Homeoffice & Hybrid or Remote Model

Training and personal development program

English lessons

Well-being programme

Internal activities & RSC Activities

Formación

• 2 years experience in Pharmacovigilance departments.
• Fluency in both English (C1) and Spanish is required.
• Possess advanced IT skills, particularly in MS Office.

Responsabilidades

• Perform weekly global / local literature assessments.
• Manage Individual Case Safety Reports (ICSRs), Adverse Events (AEs), and follow-up activities.
• Oversee the maintenance of the Pharmacovigilance System and prepare various reports.

Conocimientos

Fluent in English (C1)

Fluent in Spanish

Advanced IT skills (MS Office)

Proactive

Good communication

Detail-oriented

Teamwork

Educación

Academic Degree in Life Science and Pharmacovigilance

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.