Working in various therapeutic areas on a wide range of tasks -Do you want to contribute to safe innovative drugs?
At Julius Clinical, science is the foundation. Our internationally recognised academic leaders are actively involved in the design, conduct, and interpretation of (international) clinical trials. This scientific expertise and credibility combined with operational excellence means that we are uniquely equipped to assist in providing answers for today’s clinical drug development challenges. What we offer are end-to-end CRO services in specific therapeutic areas, such as cardiology and metabolic, CNS, infectious diseases and immunology based on our scientific expertise.
At this moment we have an interesting opportunity for a communicative and self-motivated Safety Specialist. Our new Safety Specialist will manage and conduct clinical safety activities for the assigned projects. These activities will be performed in accordance with applicable legislation, guidelines and directives in order to ensure the proper execution of processes for clinical safety reporting. You will support and give advice to the project teams and provide clinical safety input for proposals and bid defences to the Business Development department.
You will work on various (international) studies on different therapeutic areas and collaborate with all departments within Julius Clinical. It is a diverse, challenging job in an organisation with direct communication lines, with excellent opportunities to put your ideas for improvement into practice. The safety specialist will report to the Manager Medical & Safety.
Tasks and responsibilities
- Be responsible for the process of safety reporting of the individual subjects participating in clinical trials within applicable regulations and according to EU Directive, guidelines;
- Manage individual case reports (Serious Adverse Events, SUSARS, Adverse Drug Reactions), reconciliation of SAEs, coding and data retrievals from the safety database; realize deadlines for health authority requests and submissions;
- Collect required data for the Safety Physician with regard to (clinical safety) reports and documents, e.g. safety sections in submission documents and periodic reports such as Development Safety Update Report (DSUR), Medical Monitoring according to the set timelines and quality of designated projects;
- Ensure the implementation of latest clinical safety requirements to the standardized clinical trial processes by all parties involved in the applicable clinical trials, including translation into business processes (SOP,WI);
- Run various studies in different therapeutic areas;
- Collaborate effectively in (study) teams within the organisation and represent the Medical & Safety Department during in- and external meetings;
- Coordinate, support and provide safety input and activities to internal and external clients during all phases of the study;
- Ensure safety reports and documents are in place and handled according to the set timelines and quality of designated projects;
- Ensure all necessary procedures, systems, tracking tools and documents are in place;
- Provide, in collaboration with the Medical and Safety manager, safety input into proposals, bid defences and protocols;
- Have contact with external parties, such as vendors;
- Keep abreast of new developments in international legislation and guidelines with regard to clinical safety in clinical trials.
- Higher level of education, preferably in a pharmaceutical-or, a (para) medical field e.g. medicine, medical science, pharmacy, biomedical sciences or life sciences;
- A minimum of 2 years of experience in clinical safety in various phases of drug development in a (global) pharmaceutical company or (global) CRO;
- Preferable familiar with Pharmacovigilance / with safety databases such as PV 24/7;
- Extensive knowledge of clinical safety legislation and regulations and ICH-GCP guidelines;
- Excellent (English) oral and written communication skills;
- Self-motivated, analytical, decisive, flexible, result driven, proactive; go-getter.
- An open culture in an innovative environment in which science is inseparable from your daily activities;
- Training and support to preserve and further develop your knowledge and skills as medical professional;
- Good working conditions (e.g. flexible working hours, possibilities to work from home);
- During the Covid-period we are working from home
- We are located in a beautiful monumental building, close to Slot Zeist; close to public transport (busses and train station Driebergen-Zeist).