Descripción de la oferta
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.
Requirements
2 years experience in Pharmacovigilance departments.
Advanced IT level – (MS Office)
Academic Degree in Life Science and Pharmacovigilance.
Proactive, good communication, accurate, detail orientated, teamwork.
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.
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