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 Support clinical trial safety activities in a pre-marketing environment. Manage, assess and follow up AESIs, SAEs, and SUSARs from clinical studies into the Safety database ( experience with Argus, e Ve Report is a plus). Ensure timely and compliant case processing and reporting through Eudra Vigilance and MHRA portal . Support and contribute to pharmacovigilance and safety submissions at EU and ROW level , ensuring compliance with applicable local and integral requirements. Perform reconciliations with clinical databases to ensure consistency and completeness of safety data. Manage safety-related queries and follow up with relevant stakeholders to ensure accurate and timely resolution. Work with e CRF data as part of safety data review, follow-up, and reconciliation activities. Ensure appropriate filing of pharmacovigilance and clinical safety documentation in the e TMF , according to study requirements and internal procedures. Generate and review line listings (LLs) and contribute to the analysis of safety data outputs. Prepare, review, and maintain Safety Management Plans (SMPs) in line with study and client requirements. Contribute to Annual Safety Reports (ASR) elaboration .



Work closely with sponsors, regulatory teams, and cross-functional stakeholders. Draft and review Pharmacovigilance Agreements and provide strategic safety input. Support internal training and contribute to continuous improvement of pharmacovigilance processes. 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 premarketing activities. Advanced IT level – (MS Office) Academic Degree in Life Science or Pharmacovigilance. Proactive, good communication, accurate, detail orientated, teamwork Why working at Asphalion? 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. 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.

📌 Drug safety senior officer (Madrid)
🏢 Asphalion
📍 Madrid