Be part of the future of drug safety at Asphalion We’re looking for a Drug Safety Senior 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 Main

responsibilities:
• Perform weekly general/local literature assessments.
• Efficiently manage post-marketing activities including 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 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:
• +4 years experience in Pharmacovigilance departments, with strong exposure to post-marketing activities.
• Fluent in English & Spanish
• Advanced IT level – (MS Office)
• Academic Degree in Life Science or 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 Commitment, Quality, Teamwork, Adaptability, Innovation & Purpose-led. ?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 ✅ Equal Opportunity Employer

📌 Drug Safety Senior Officer (Madrid)
🏢 Asphalion
📍 Madrid