Clinical Safety Physician
Hobson Prior are looking for a Clinical Safety Physician to join an innovative biotech company who are focused on the development of Oncology products. This role will be accountable to manage safety information and medical reviews in clinical trials.
- Accountable for all aspects of safety related to products in development, including individual case assessment, aggregate reporting, signal detection, risk management throughout the life cycle.
- Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information.
- Support the Clinical team in bringing the safety expertise in interaction with Heath Authorities, Data Monitoring Committees and Investigators.
- Review, contribute and provide medical and safety expertise for investigator brochures, protocols, informed consent, CRFs, clinical study reports, briefing books and other safety related documents.
- Contribute to the design of the clinical development plan throughout the development of the product.
- Be a core member of the Project Team and the Drug Safety representative with other functions and departments as required.
- Excellent communication, organizational, problem-solving, and interpersonal skills and the ability to meet timelines.
- Is willing to be part of interdisciplinary teams, to work collaboratively with spirit of initiative and proactivity.
- Fluency in English is required.
- Doctor of Medicine degree is required.
- A minimum of 5 years' experience in the drug safety environment of pharmaceutical or biotechnology industry with expertise in all phases of drug development are required.
- Solid scientific background and clinical development knowledge, experience and ability to interpret clinical study safety information is required.
- Knowledge of international safety regulations (primarily ICH-GCP, EU and FDA regulations) is required.
- A background in Immunology/Autoimmune diseases and/or Oncology would be an advantage.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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