TFS HealthScience is excited to be expanding our Strategic Resourcing Solution team and we are looking for an experienced, highly motivated Drug Safety Officer (DSO) who shares our vision of providing clinical research excellence. The Drug Safety Officer is part of the Project Delivery organization and will work on handling of drug safety/vigilance issues according to company policies, SOPs and regulatory requirements.
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.
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
Review and approval of processed cases and AE/SAE reconciliation
Coding of adverse event, medical history and concomitant medication according to MedDRA and WHO-Drug Dictionary
QC and approval of coding of adverse event, medical history and concomitant medication
Review and write the safety section in clinical study protocols
Review of clinical trial reports/IBs from a safety perspective
Write the safety parts in the PSUR/PBRER, DSURs, IND, NDA and other safety documents
Electronic reporting to EudraVigilance
Contribute to plans/instructions and SOPs for post approval surveillance
Updating of templates for safety handling in specific studies/projects according to relevant SOPs
May act as a Project Lead for Safety-only projects
Participate in relevant meetings. Forward information to relevant members of the department or study team members
Provide internal support to other relevant departments
Involved in improvement projects with other relevant departments
Actively contribute to the organization and development of routines to enhance the work at TFS
Validation of computer applications specific for the department with respect to drug safety requirements
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.
Education and supervision of new Drug Safety personnel
Participate in marketing activitiesRequirements
- Bachelor’s Degree, preferably in life science or nursing; or equivalent
- 5 years of relevant experience
- Able to work in a fast-paced environment with changing priorities
- Understand the medical terminology and science associated with the assigned drugs and therapeutic areas
- 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
- Demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus
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.