Clinical Safety Specialist
- Experience Level
- Experienced (non-manager)
Our Client is an innovative R&D Biotech that has many agents at various trial phases and successfully achieved FDA Approval in 2015 for a new medical device within Oncology. They have a start up feel about them which creates a fast-paced, highly dynamic and entrepreneurial culture with an emphasis on being patient centric. They went “live” in 2015, so they are still setting and building up the structures and processes and are now in a role out phase for their new product. They are looking for a Clinical Safety Specialist for a permanent position to be based in the Lucerne area.
The ideal candidate should have 3+ years of active clinical experience or previous medical device/ drug safety-related experience in multinational clinical trials, familiarity with regulatory affairs and experience in clinical research in oncology.
As a Clinical Safety Specialist you are responsible to implement and oversee all areas of safety monitoring and reporting for clinical trials.
- Process, assess and critically review adverse event data;
- Maintenance of safety report database;
- Prepare periodic safety reports;
- Respond to regulatory safety queries;
- Interface with Contract Research Organizations (CROs), project team members and clinical trial sites;
- Train others on safety related topics internally and externally;
- Support the development of safety monitoring plans for the clinical trials;
- Ensure activities comply with the applicable Quality System requirements.
Qualifications and Experience
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- Bachelor's level degree preferably in nursing, pharmacy or other health related profession, or degree as Registered Nurse/ Medical Doctor;
- 3+ years of active clinical experience or 2+ years of medical device/drug safety-related experience in multinational clinical trials;
- Familiarity with regulatory affairs in Europe and North America;
- Experience in clinical research in oncology;
- Understanding of European and North American regulatory systems for clinical trials;
- Accredited GCP course is a plus;
- Highly self-motivated, pro-active and flexible with independent working style and good organizational skills;
- Proficiency with standard office skills, standard desktop computing programs and medical terminology;
- Fluency in English (verbal and written), an additional European languages is preferred.