- Our company is a Swiss drug discovery and development company, focused on the creation of antibody-based drugs for the targeted treatment of inflammatory diseases, immune-related disorders, and cancer.
- The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets.
- Four of these compounds are currently in early clinical development with the anti-IFNg monoclonal antibody program, most advanced, at Phase 2/3, for the orphan drug indication Hemaphagocytic Lymphohistiocytosis (HLH).
- Our company is currently seeking a Clinical Safety Specialist to join its Clinical Development Department.
- Reporting to the Head of Drug Safety, the selected candidate will collaborate with the team with the objective of ensuring that compliant processes and tools are in place at our company for all safety related activities.
- Maintenance of the Safety Database including validation of upgrades
- Creation and update of all Standard Operating Procedures and forms related to safety activities
- Periodic check of the safety compliance and identification of potential non-compliance areas
- Proposition and follow-up on Corrective Actions in case of detection of potential non-compliance activities
- Review of the new / revised regulatory requirements (US and EU in particular), evaluation of the impact on local processes and reporting on changes in regulations
- Preparation of safety compliance -related training activities in our company and for third parties (e.g. investigational sites, CRO) including audits and inspections preparation
- Knowledge contribution to the safety-relevant sections of protocols (Clinical Trials, Non Interventional Studies, Research Related Activities, Patient Support Programs, etc.) to ensure a legally compliant reporting
- Development and maintenance of a list of all relevant local drug safety authorities and, where appropriate, other official bodies, which transfer the reporting of adverse reaction
- Support for data entry and submission activities of single or periodic reports to third parties
- Support for recording and archiving of clinical safety information collected at investigational sites
Skills and competencies:
- Bachelor’s degree in a health related discipline
- Experience in the field of clinical drug safety and quality assurance
- Experience with GMS database systems
- Good knowledge in pharmacovigilance responsibility in the development of investigational drugs (i.e. first in class therapeutics) during preparation phase for obtaining marketing authorization Pharmaceutical industry knowledge
- Computer literacy
- Conscientious and precise operation
- Results and performance oriented approach and strong process orientation
- Good communication skills
- Ability to be flexible, adapt to change and meet deadlines with a strong attention to details
- Very good written and spoken English
- Swiss resident or EU national