Pharmacovigilance Associate — SAE & Safety Case Management

Trial Form Support; Madrid; Presencial; EUR 26.000 - 38.000; Jornada completa

Descripción de la vacante

TFS HealthScience seeks a Drug Safety Associate to join our Project Delivery team in Madrid, Spain. You will support safety case handling, code adverse events, and assist in pharmacovigilance tasks across sponsor projects in a fast-paced CRO environment.

Ideal candidates have a life science or nursing degree, understanding of GCP/ICH, and excellent written and verbal communication skills. You will collaborate across functions to ensure timely safety reporting and compliance.

Formación

• Bachelor’s degree in life science or nursing or equivalent.
• Ability to work in a fast-paced environment with changing priorities.
• Understand medical terminology and science related to the drugs and therapeutic areas.
• Knowledge of GCP, ICH guidelines, pharmacovigilance legislation and SOPs.
• Work independently or in a matrix team with minimal supervision; excellent communication.
• Proficient with common word processing and spreadsheets.

Responsabilidades

• Support SAE handling in trials and spontaneous reports per SOPs and regulatory requirements.
• Review cases and draft narratives of AE and SAE reports as required.
• Code adverse events, medical history and concomitant medication.
• Support SAE reconciliation and DCF handling.
• Correspondence and archiving.
• Assist in registration and other matters of EudraVigilance.
• Participate in relevant project groups/meetings.
• Assist internal safety-related templates per SOPs.
• Contribute to organizational routines to improve safety processes.
• Stay informed on laws and guidelines concerning pharmacovigilance and safety reporting.

Conocimientos

Communication skills

Independent worker

Teamwork

Attention to detail

GCP/ICH knowledge

Educación

Bachelor’s degree in life science or nursing

Descripción del empleo

TFS HealthScience seeks a Drug Safety Associate to join our Project Delivery team in Madrid, Spain. You will support safety case handling, code adverse events, and assist in pharmacovigilance tasks across sponsor projects in a fast-paced CRO environment.

Ideal candidates have a life science or nursing degree, understanding of GCP/ICH, and excellent written and verbal communication skills. You will collaborate across functions to ensure timely safety reporting and compliance.