About this role 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.
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 t

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