Drug Safety Officer

ASPHALION; Tarragona; Presencial; EUR 40.000 - 55.000; Jornada completa

Descripción de la vacante

Join a leading company in drug safety as a Drug Safety Officer. You'll be pivotal in managing pharmacovigilance tasks, ensuring compliance with regulations, and contributing to innovative projects. This role offers professional growth in a dynamic environment with options for remote and hybrid work.

Servicios

Permanent contract

Training and personal development program

Homeoffice & Hybrid or Remote Model

Variety of projects and challenges

Formación

• 2 years experience in Pharmacovigilance departments.
• Proactive and detail-oriented.
• Good communication skills and teamwork.

Responsabilidades

• Perform weekly global/local literature assessments.
• Manage ICSR, AEs, and follow-up activities.
• Prepare and review PSURs, RMPs, and DSURs.

Conocimientos

Communication

Attention to detail

Teamwork

Educación

Academic Degree in Life Science and Pharmacovigilance

Herramientas

MS Office

Descripción del empleo

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.

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.

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.