Drug Safety Associate

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.

• 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 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

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.

• 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