About this role
Si le interesa solicitar este empleo, por favor, asegúrese de cumplir los siguientes requisitos que se enumeran a continuación.
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 general 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 nurs

📌 Drug Safety Associate (Cataluña)
🏢 Trial Form Support
📍 Cataluña