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

About this role

TFS 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 Associate is part of the Project Delivery organization and will work 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 supervision

• Excellent 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.