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 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 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 (España)
🏢 TFS HealthScience
📍 España