TFS HealthScience is excited to be expanding our Strategic Resourcing Solution team and we are looking for an experienced, highly motivated Drug Safety Physician (DSP) who shares our vision of providing clinical research excellence. Our Drug Safety team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation. Together we make a difference.
TFS HealthScience is looking for a Drug Safety Physician (DSP) to be working fully outsourced to one of our prestigious pharmaceutical clients home based from Denmark.
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.
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
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
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
What can we offer you?
A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. Benefits include:
- Entrusted work time
- Fitness Contribution
- Health Insurance
- Life insurance
- Global General Liability Insurance
- Global Travel Insurance