At Julius Clinical, science is the foundation. We are focusing on the development of new and innovative medicine that have a major impact on people’s lives. We perform clinical trials in therapeutic areas such as cardiology, diabetes, CNS and infectious diseases. At this moment we have an interesting opportunity for a Safety Physician.
Our new Safety Physician will manage and provide all medical and safety aspects of our clinical trials, will also be involved in protocol reviewing and provide scientific input. You will work in a close-knit team of responsible colleagues. It is a diverse job in an organisation with short lines, with excellent opportunities to put your ideas for improvement into practice. The Safety Physician reports to the Manager Medical and Safety.
Tasks and responsibilities
Clinical study level:
- Provides medical and safety input into proposals, bid defences and protocols;
- Coordinates, supports and provides medical and safety input and activities to internal and external clients during all phases of the project, including periodic status reporting of the designated project(s);
- Ensures in collaboration with Safety Specialists, safety reports and documents are in place and handled according to the set timelines and quality of designated projects;
- Ensures all necessary procedures, systems, tracking tools and documents are in place;
- Represents the department during in- and external meetings;
- Collaborates effectively in (project) teams.
Individual patient care:
- Adjudicates, advances and safeguards the health of individual subjects by medical review, medical monitoring (including but not limited to: adverse events, medication, diagnostics) and signal management (early signals will be detected to ensure safety of subjects);
- Advises and informs investigators and sponsor on medical issues;
- Advises and informs ethical committees and regulatory authorities on medical issues;
- Advises investigators and sponsor on eligibility (compliance to all inclusion and exclusion criteria);
- Participates in safety committees and data review meetings as safety expert;
- Responsible for the process of safety reporting of the individual subjects participating in clinical trials within applicable regulations and according to EU Directive, guidelines;
- Advises on continuation of trial drug– if applicable.
- Medical Degree (MD) with a minimum of 5 years of experience in the pharmaceutical and/or CRO industry or equivalent clinical research experience;
- Preferably previous experience with pharmacovigilance/drug safety;
- Excellent (English) oral and written communication skills;
- Analytical, decisive, flexible, result driven, proactive;
- Ability to balance medical competence with industry standards to achieve business goals.
- 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).