Clinical Safety Manager
The position is required to implement and oversee all areas of safety monitoring and reporting for clinical trials. The Clinical Safety Manager is based in the company’s headquarters in Lucerne, Switzerland.
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 Manager for a permanent position to be based in the Lucerne area.
The ideal candidate should have 5 years of previous experience with active clinical experience or 3 years of medical device/drug safety-related experience in multinational clinical trials.
- Medical monitoring of safety data;
- Review and approval of safety reports prior to submission;
- Assess, critically review and sign off serious adverse event (SAE) case reports;
- Ensure proper maintenance of safety report database;
- Support the preparation of periodic safety reports;
- Respond to regulatory safety queries;
- Provide sponsor oversight of SAE processing by outsourced vendors;
- Provide support for external submissions, signal detection and risk management planning activities;
- Ensure compliant exchange of safety information between the company and its partners;
- 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:
- Medical degree (MD) required;
- Minimum of 5 year active clinical experience or 3 years of medical device/drug safety-related experience in multinational clinical trials;
- Familiarity with regulatory affairs in Europe and North America and experience clinical research in oncology;
- Understanding of European and North American regulatory systems for clinical trials;
- Accredited GCP course;
- Must be highly self-motivated, pro-active and flexible with independent working style and good organizational skills;
- Fluency in English (verbal and written), additional European languages preferred;
- Relevant working/residency permit or Swiss/EU-Citizenship required.