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.
Employment Type : Full Time
Experience: years
Vacancy: 1