Description
We are looking for a
Safety Programmer Medical Surveillance (m/f)
Reference: -en
Start: 03/17
Duration: 6 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- 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
Your qualifications
- 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
Skills:
- Biostatistician
- Drug safety manager