ppBe part of the future of drug safety at Asphalion! We’re looking for a bDrug Safety Senior Officer /b 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! /ph3Main responsibilities: /h3ulliPerform weekly global/local literature assessments. /liliEfficiently manage post-marketing activities including Individual Case Safety Reports (ICSRs), Adverse Events (AEs), and follow-up activities. /liliManage cases through the Pharmacovigilance Database and report accurately to European authorities via EudraVigilance. /liliTranslate relevant pharmacovigilance information into English and liaise with Spanish Regulatory Authorities. /liliProvide support to local and EU Qualified Persons for Pharmacovigilance (EUQPPv). /liliStay informed about updates in global and local pharmacovigilance regulations. /liliOversee the maintenance of the PSMF and Asphalion’s Pharmacovigilance System (SOPs). /liliPrepare and review PSURs, RMPs and ACOs with attention to detail. /liliOffer expert medical advice and support Medical Information projects. /liliDraft and review Pharmacovigilance agreements and provide strategic insights. /liliPrepare and conduct internal Pharmacovigilance training sessions.



/li /ulpIf 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! /ph3Requirements: /h3ulli+4 years experience in Pharmacovigilance departments, with strong exposure to post-marketing activities. /liliAdvanced IT level – (MS Office) /liliAcademic Degree in Life Science or Pharmacovigilance. /liliProactive, good communication, accurate, detail orientated, teamwork /li /ulh3Why working at Asphalion? /h3pFlexible working schedule - Friday until 15.30h. /ppHomeoffice Hybrid or Remote Model b(You can be located anywhere in Spain!) /b /ppWide variety of projects, new challenges and experiences. /ppTraining and personal development program. /ppA 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. /ppA highly dynamic working environment with employees from more than 15 nationalities. /ppOur people and their well-being are our priority: Physical, psychological and emotional well-being programme. /p /p #J-18808-Ljbffr

📌 Drug Safety Senior Officer (Italia)
🏢 ASPHALION
📍 Italia