Beschreibung
The Safety Scientist supports the safety risk management of assigned products across the lifecycle including early and late phase development safety activities as well as safety activities for marketed products.In collaboration with the safety science product responsible the Safety Scientist is:
? Responsible for aggregate case reporting activities and aggregate reporting (e.g., DSUR, PBRER)
? Responsible for signal detection and management activities including, including respective documentation 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 cross-functional teams 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
? Coordinates and assists in Health Authority interactions and responding to requests
? Responsible for supporting processes involving safety science
? Responsible for carrying out activities related to quality system management for safety science
Skills and Experience:
? Minimum: Bachelor’s degree in healthcare related field or equivalent experience
? Work experience in pharma safety, pharmacovigilance or other related pharmaceutical development area of at least 2 years
? Appreciation of GVP and GCP 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
? Excellent communication skills, both written and verbal
? Fluent in English