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 Scientist. The ideal candidate should have at least 3-5+ years of experience in pharma safety, pharmacovigilance or other related pharmaceutical development area and have been responsible for writing aggregate reports (i.e. DSUR, PBRER), aggregate case reporting activities including ICSR case management (medical review).
- Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER);
- Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance, and drug safety reports;
- Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS;
- Contributing to study management through SMT/PET and document review across the development continuum (early phase to post marketing studies), including PASS;
- Interfacing with business process owners on processes executed by Safety Science;
- Coordinate and assist in responding to Health Authority requests;
- Supporting product quality issues;
- Responsible for carrying out activities related to quality system management for safety science.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- Bachelor’s degree in healthcare related field or equivalent experience;
- At least 3 year of experience working in pharma safety, pharmacovigilance or other related pharmaceutical development area preferred; Appreciation of GxP and regulated processes and end to end clinical trial lifecycle;
- Understanding on application of data analysis / statistical methods to evaluate, interpret and present scientific data with clarity;
- Able to work with remote partners and teams across global sites.