Pharmacovigilance Specialist

Be part of the future of drug safety at Asphalion We’re looking for a Pharmacovigilance Specialist 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.

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.