TFS HealthScience is a leading integral 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.
Join Our Team as a Drug Safety Associate - home based in Portugal, Poland, Spain, UK or Sweden (hybrid).
About this role
As part of our Ophthalmology Drug Safety team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Drug Safety Associate is is part of the Project Delivery organisation and will work with assistance on handling of drug safety/vigilance issues according to company policies, SOPs and regulatory requirements.
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

📌 Drug Safety Associate (Barcelona)
🏢 TFS HealthScience
📍 Barcelona