Drug Safety Associate

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

About this roleTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.The Drug Safety Associateis part of the Project Delivery organization and willwork with assistance on handling of drug safety/vigilance issues according to company policies, SOPs and regulatory requirements.As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.

Key Responsibilities

• Support to handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the TFS/clients’ SOPs and existing demands of the authorities
• May review cases and write draft narratives of AE and SAE reports, as required
• May code adverse events, medical history and concomitant medication
• Support to SAE-reconciliation DCF handling
• Correspondence and archiving
• Assist in registration and other matters of EudraVigilance
• Participate in relevant project groups/meetings
• Assist in internal support to other relevant departments
• May provide updates of templates for safety handling in specific studies/projects according to relevant SOPs
• Actively contribute to the organization and development of routines to enhance the work at TFS
• Being well-informed and updated on laws, directives and guidelines concerning handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues

Qualifications

• Bachelor’s Degree, preferably in life science or nursing; or equivalent
• Able to work in a fast-paced environment with changing priorities
• Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas
• Have the basic understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs
• Ability to work independently as well as in a team matrix organization with little or no supervisionExcellent written and verbal communication skills
• Demonstrate proficiency using typical word processing; spreadsheets desirable

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.