¡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!
Key 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.
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:
+2 years experience in Pharmacovigilance departments.
Fluent in English & Spanish
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