Safety Programmer Medical Surveillance (m/f)

REFERENZNUMMER:

323276/1

IHRE AUFGABEN:

-Develop standard and ad hoc safety outputs (within business intelligence platform or based on SQL query) according to applicable Quality System documents
-Perform quality control (e.g. double programming) of outputs produced within the team
-Conduct routine and ad hoc safety data extraction (i.e. DSURs, PBRERs, health authority request, audit/inspections)
-Assess and interpret system and business requirements originating from various sources (e.g. safety medical and operation teams, system teams, clinical teams etc.)
-Partner with team members in order to provide consistency and quality in the deliverables
-Provide support to users of the business intelligence platform

IHRE QUALIFIKATIONEN:

-University degree (bachelor, master or equivalent) in computer science
-Profound experience in programming within a pharmaceutical company or a clinical research organization, preferably in the drug safety area
-Strong technical knowledge in database query (SQL on Oracle database) and business intelligence reporting tool (Oracle Business Intelligence Enterprise Edition)
-Team player mentality and good communication skills in interlocutions with technical and non-technical persons
-Ability to analyze technical and business processes and translate them into business requirements
-Fluency in English, both verbal and written
-Good knowledge in quality assurance for regulated computerized systems (FDA 21CFR part 11, GxP, EU directives & guidelines)
-Knowledge of medical and pharmacovigilance terminologies, e.g. MedDRA

WEITERE QUALIFIKATIONEN:

Drug safety manager, Biostatistician