Drug Safety Associate

TFS HealthScience•Barcelona, United Kingdom

23h•Hybrid

About The Position

TFS HealthScience is a global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout clinical development. The Drug Safety Associate will join the Ophthalmology Drug Safety team within the Project Delivery organization and, with assistance, handle drug safety and pharmacovigilance matters in accordance with company policies, SOPs, and regulatory requirements. The role is home based in Portugal, Poland, Spain, the UK, or Sweden, with the posting also describing the arrangement as hybrid. The associate supports safety case processing for clinical trial serious adverse events (SAEs) and spontaneous market reports, including collection, assessment, and entry into the safety database. Other duties may include reviewing cases and drafting narratives, coding adverse events and related medical information, supporting SAE reconciliation, handling data clarification forms and correspondence, assisting with EudraVigilance matters, and contributing to project meetings and internal support. The role also contributes to safety templates and organizational routines, and requires staying current with applicable laws, directives, guidelines, and safety-reporting requirements. TFS offers a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a collaborative and innovative environment. The company states that its vacancies in Spain are open to people with disabilities in accordance with applicable Spanish law. TFS reports that it has more than 600 professionals and delivers clinical research services in more than 50 countries.

Requirements

Bachelor’s degree, preferably in life science or nursing, or equivalent.
Ability to work in a fast-paced environment with changing priorities.
Basic understanding of medical terminology and the science associated with assigned drugs and therapeutic areas.
Basic understanding of Good Clinical Practice regulations, ICH guidelines, pharmacovigilance legislation, and internal SOPs.
Ability to work independently and within a team matrix organization with little or no supervision.
Excellent written and verbal communication skills.
Proficiency with typical word-processing software.

Nice To Haves

Spreadsheet skills are desirable.

Responsibilities

Support the handling of clinical trial SAEs and spontaneous market reports, including collection, assessment, and entry into the safety database in accordance with TFS and client SOPs and regulatory requirements.
Review cases and draft narratives for AE and SAE reports, as required.
Code adverse events, medical history, and concomitant medication, as required.
Support SAE reconciliation.
Handle DCFs.
Manage correspondence and archiving.
Assist with EudraVigilance registration and other related matters.
Participate in relevant project groups and meetings.
Provide internal support to other relevant departments.
Update templates for safety handling in specific studies or projects according to relevant SOPs, as required.
Contribute to the organization and development of routines to enhance work at TFS.
Stay informed about laws, directives, and guidelines concerning SAE handling and reporting in clinical trials, serious and non-serious market events, and other safety issues.