Safety trainee

ASPHALION is an international Regulatory, Scientific & Safety consultancy company founded in 2000. Its strong track record has made ASPHALION a reference in the international healthcare sector and a key stakeholder in the implementation of new regulatory standards. ASPHALION’s experts have delivered solutions to over 1,000 Pharmaceutical, Biotechnological and Medical Technology companies from more than 50 countries in over 5,000 projects covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for both medicinal products and medical devices. ASPHALION offers strategic advice, expert consulting, operational support, as well as full outsourcing services for all types of products in all therapeutic areas. We are currently seeking a motivated Drug Safety Trainee to join our Pharmacovigilance team in Pamplona. This is an excellent opportunity for individuals looking to start their career in drug safety and pharmacovigilance. As a trainee, you will learn and provide support to the team in the following tasks: Weekly global or local literature review Handling of ICSRs and follow-up Contact with the Spanish Regulatory Authorities Assistance Qualified local contact in Spain for pharmacovigilance Keep Client informed about local pharmacovigilance legislation Informing and updating the company about all changes regarding the requirements of the local Regulatory Authorities Maintenance PSMF and Asphalion Pharmacovigilance System (SOPs) Preparation of PSURs, RMP, PSMF, CCSI Reporting of cases to the European authorities through EudraVigilance Case processing of non-serious cases through data base Candidate Profile: Bachelor's degree in sciences Currently pursuing a Master's degree, with the requirement of being actively enrolled and having the possibility of establishing an internship agreement. High level of English, both spoken and written (C1). Excellent computer skills. Why working at Asphalion? # ;️Internship agreement # ; Flexible working schedule - Friday until 15.30h. # ; Homeoffice & Hybrid or Remote Model (Pamplona based) ⚙️ 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