Drug Safety Associate

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 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

• Bachelors 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 the assigned drugs and therapeutic areas

• Have the basic understanding of the Good Clinical Practice regulations ICH guidelines Pharmacovigilance legislation and internal SOPs

• Ability to work independently as well as in a team matrix organization with little or no supervision

• Excellent written and verbal communication skills

• Demonstrate proficiency using typical word processing; spreadsheets desirable

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration quality and making a difference in the lives of patients.

Our core values of Trust Quality Passion Flexibility and Sustainability guide our decisions and shape our culture. By aligning on these values we foster collaboration innovation and a shared commitment to excellence. Together we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden in the city of Lund. As a full-service global CRO we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals TFS delivers tailored clinical research services in more than 50 countries offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.