Drug Safety Officer

¡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!

Main 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 :

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

✅ Equal Opportunity Employer