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.
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:
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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
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May review cases and write draft narratives of AE and SAE reports, as required
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May code adverse events, medical history and concomitant medication
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Support to SAE-reconciliation
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DCF handling
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Correspondence and archiving
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Assist in registration and other matters of EudraVigilance
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Participate in relevant project groups/meetings
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Assist in internal support to other relevant departments
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May provide updates of templates for safety handling in specific studies/projects according to relevant SOPs
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Actively contribute to the organization and development of routines to enhance the work at TFS
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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:
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Bachelor’s Degree, preferably in life science or nursing; or equivalent
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Able to work in a fast-paced environment with changing priorities
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Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas
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Have the basic understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs
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Ability to work independently as well as in a team matrix organization with little or no supervision
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Excellent written and verbal communication skills
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Demonstrate proficiency using typical word processing; spreadsheets desirable
What We Offer
We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
For candidates based in Spain - TFS is committed to equal opportunities. All our vacancies are open to people with disabilities, in accordance with the General Law on the Rights of Persons with Disabilities (Royal Legislative Decree 1/2013).
A Bit More About Us
Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.
Together we make a difference.