(Fo347) - Drug Safety Officer

Asphalion; Madrid; Presencial; EUR 35.000 - 50.000; Jornada completa

Descripción de la vacante

Asphalion recherche un Drug Safety Officer passionné par la sécurité des médicaments et désireux d'évoluer professionnellement. Vous serez responsable de la gestion des rapports de cas de sécurité, des audits et de la conformité réglementaire, tout en travaillant dans un environnement dynamique et inclusif. En intégrant notre équipe, vous contribuerez à l'innovation en pharmacovigilance et bénéficierez d'une culture d'entreprise axée sur la passion et la qualité.

Servicios

Contrat permanent

Horaires flexibles

Programme de développement personnel

Leçons d'anglais

Bien-être physique, psychologique et émotionnel

Formación

• Expérience de plus de 2 ans dans des départements de Pharmacovigilance.
• Maîtrise de l’anglais et de l’espagnol.
• Niveau avancé en informatique (MS Office).

Responsabilidades

• Réaliser des évaluations littéraires globales/locales.
• Gérer les rapports de cas individuels (ICSR) et les événements indésirables (AE).
• Préparer et examiner des PSUR, RMP et DSUR.

Conocimientos

Communication

Attention to Detail

Teamwork

Proactivity

IT Skills

Educación

Diplôme en Sciences de la Vie

Formation en 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 Eudra Vigilance.

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.

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