CTC Resourcing Solutions, founded in Basel, Switzerland in 1997, is a pan-European specialist staffing organisation with offices in Basel and Cologne, providing flexible resourcing solutions to the pharmaceutical industry across Europe, with contract and permanent placements in clinical development, data management, statistics, regulatory affairs and medical marketing.
For our pharmaceutical clients in Switzerland we are constantly looking to connect with experienced professionals in several areas, including pre-clinical development, clinical research, medical affairs, regulatory affairs, etc.
One of the roles we often recruit for is Drug Safety Physician. The ideal candidate should have 5- 8 years of experience in Clinical and post-marketing safety in the pharmaceutical or biotechnology industry.
- Accountable for all aspects of safety related to the assigned projects/products including medical assessment, aggregate reporting, signal detection, risk management, and risk minimization activities throughout the product’s life cycle;
- Take care of all aspects of safety related to products in development, including single case assessment, aggregate reporting, signal detection, risk management throughout the life cycle;
- Establish safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate in order to ensure that adequate measures based on safety findings are taken;
- Support the Clinical team in bringing the safety expertise in interaction with Heath Authorities, Data Monitoring Committees and Investigators;
- Create safety sections in the study protocols, Investigator’s Brochures and all required safety 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.
Qualifications and Experience:
- Doctor of Medicine degree with at least 5-8 years of experience in clinical safety in the pharmaceutical or biotechnology industry;
- Experience in a clinically complex area as Immunology/ Autoimmune diseases and/or Oncology, Hematology would be an advantage;
- Excellent medical writing, presentation and communication skills;
- Good experience and knowledge with safety signal identification methodology and risk minimization measures;
- Knowledge of global safety regulations, Good Clinical Practice (GCP) and Pharmacovigilance compliance requirements;
- Willing to be part of interdisciplinary teams with spirit of initiative and proactivity;
- Excellence in written and spoken English;
- Relevant working/residency permit or Swiss/EU-Citizenship required.