Pharmacovigilance & Drug Safety Associate

TFS HealthScience; Barcelona; Presencial; EUR 38.000 - 46.000; Jornada completa

Descripción de la vacante

TFS HealthScience, a leading global mid-size CRO, seeks a Drug Safety Associate to support SAE handling, pharmacovigilance activities, and safety data management across sponsor projects. You will collaborate with cross-functional teams, ensure regulatory compliance, and contribute to safety reporting as part of the SRS/FSP organization.

The role requires a life sciences or nursing background, ability to work in a fast-paced setting, and strong communication skills.

Formación

• Bachelor’s Degree in life sciences or nursing or equivalent
• Able to work in a fast-paced environment with changing priorities
• Understand basic medical terminology and science of assigned drugs
• Knowledge of GMP/ICH pharmacovigilance guidelines and SOPs recommended
• Ability to work independently and in a matrix team
• Excellent written and verbal communication skills
• Proficiency with common word processing and spreadsheets is beneficial

Responsabilidades

• Support SAE handling in clinical trials and spontaneous reports
• Review cases and draft AE/SAE narratives as required
• Code adverse events, medical history, and concomitant medication
• Support SAE reconciliation and data handling
• Assist in registration and reporting to EudraVigilance
• Participate in project groups/meetings and internal support
• Update safety handling templates per SOPs
• Stay informed on pharmacovigilance regulations and safety reporting

Conocimientos

Communication skills

Teamwork

Attention to detail

Proficiency with MS Word/Excel

Educación

Bachelor’s degree in life sciences or nursing

Descripción del empleo

TFS HealthScience, a leading global mid-size CRO, seeks a Drug Safety Associate to support SAE handling, pharmacovigilance activities, and safety data management across sponsor projects. You will collaborate with cross-functional teams, ensure regulatory compliance, and contribute to safety reporting as part of the SRS/FSP organization.

The role requires a life sciences or nursing background, ability to work in a fast-paced setting, and strong communication skills.