Basilea Pharmaceutica International Ltd., Allschwil
Manufacturer
www.basilea.com/Allschwil, SwitzerlandAbout
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com
Areas of activity
Pharmacovigilance Operations
Individual Case Safety Report (ICSR) managementSignal detection and evaluationRisk Management Plan (RMP) developmentBenefit-Risk assessmentAggregate report writing (e.g., DSURs, PBRERs)Literature screening and follow-up procedures
Regulatory Affairs & Compliance
PV regulatory intelligence (GVP, FDA, local guidelines)Pharmacovigilance System Master File (PSMF / PSSF)GVP inspection preparedness and survival strategiesLocal and global PV compliance oversightLegal and quality assurance in safety functions
Medical Affairs & Patient Safety
Post-Trial Access (PTA) and ethical safety oversightCollaboration with medical affairs and clinical opsIntegrating medical and safety functions
Risk Management & Strategy
Global pharmacovigilance strategySafety governance and cross-department alignmentStrategic risk communication (e.g., DHPCs)Organizational leadership in safety functionsPortfolio-level benefit-risk strategy