Senior Drug Safety Officer

At Asphalion, we are looking for a Drug Safety Senior Officer to join our Pharmacovigilance team. This is a great opportunity for an experienced professional with solid knowledge of drug safety activities for medicinal products who is looking to grow in an international and dynamic environment.Main responsibilities:Conduct global and local literature screening and assessment on a weekly basis.Manage post-marketing pharmacovigilance activities, including ICSRs, adverse events, and follow-up.Process safety cases in the Pharmacovigilance Database and ensure accurate reporting to EudraVigilance and relevant authorities.Translate pharmacovigilance-related content into English and liaise with Spanish Regulatory Authorities when needed.Support local QPPVs and the EU QPPV in operational and compliance-related activities.Stay up to date with global and local pharmacovigilance regulations.Contribute to the maintenance of the PSMF, SOPs, and the Pharmacovigilance Quality System.Prepare and review PSURs, RMPs, and other pharmacovigilance documentation.Provide support for Medical Information projects.Draft and review Pharmacovigilance Agreements.Prepare and deliver internal pharmacovigilance training.

Requirements

At least 4 years of experience in pharmacovigilance.Strong experience in human medicinal product pharmacovigilance. Veterinarian Pharmacovigilance and Vigilance for medical devices are a plus.Good understanding of the full pharmacovigilance lifecycle.Hands-on experience with ICSR processing, literature review, EudraVigilance reporting, and post-marketing activities.Experience with PSURs, RMPs, PSMF, SOPs, and Pharmacovigilance Agreements.Good knowledge of EU pharmacovigilance regulations; Spanish local requirements are a plus.Strong organizational and communication skills.· Professional fluency in English and Spanish.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