Drug Safety Officer – Pharmacovigilance

About the role

Asphalion is seeking a Drug Safety Officer to join its international pharmacovigilance team. The role involves monitoring drug safety data, ensuring regulatory compliance and supporting medical information projects across Europe. You will work remotely from anywhere in Spain, collaborating with cross‑functional experts to protect patient health.

Key responsibilities

• Conduct weekly global and local literature assessments related to drug safety.
• Manage Individual Case Safety Reports (ICSRs) and adverse event follow‑up activities.
• Enter and maintain cases in the pharmacovigilance database and submit reports to European authorities via EudraVigilance.
• Translate pharmacovigilance information into English and coordinate with Spanish regulatory authorities.
• Support local and EU Qualified Persons for Pharmacovigilance (EUQPPv) and stay updated on regulatory changes.
• Maintain the Pharmacovigilance System Master File (PSMF) and related SOPs.
• Prepare and review PSURs, RMPs, DSURs and ACOs with high accuracy.
• Provide medical expertise for Medical Information projects and draft pharmacovigilance agreements.
• Design and deliver internal pharmacovigilance training sessions.

Required profile

• At least 2 years of experience in a pharmacovigilance department.
• Academic degree in Life Sciences or a related field.
• Fluent English (C1) and Spanish.
• Proactive, detail‑oriented and strong team player.

Required skills

• Advanced proficiency with MS Office.
• Experience using EudraVigilance and pharmacovigilance databases.

What we offer

• Permanent contract with flexible working hours (Friday until 15:30).
• Remote or hybrid work model – you can be based anywhere in Spain.
• Access to training, personal development programs and English lessons.
• Inclusive, high‑performance environment with employees from over 15 nationalities.
• Well‑being programmes covering physical, psychological and emotional health.