Drug Safety Programmer
Our client, a growing, dynamic biopharmaceutical company is looking for a Drug Safety Programmer for a permanent position based in Basel, Switzerland. The ideal candidate should have previous working experience in programming and strong knowledge of medical and pharmacovigilance terminologies.
- Develop standard searches and ad hoc outputs within business Intelligence tool or based on SQL query for aggregated Periodic Safety reports, Health Authorities requests, compliance and case processing monitoring.
- Work closely with the Safety Reports leader and Drug Safety Physician for standardization and maintenance of search criteria and outputs.
- Contribute to in house system development projects (Business Intelligence solution: front end and back end parts) in Global Drug Safety/Clinical Development
- Management of the system release process, including system configuration, outputs generation, coordination of validation activities and execution of testing.
- Contribute to compliance in Computerized Systems Validation requirements, GxP & Pharmacovigilance standards
- Coordination and provision of end user trainings
Qualifications and Experience:
- University Master’s Degree in Computer science, Information systems, mathematics, life -sciences or related discipline
- Minimum of 3 years of experience in programming within a pharmaceutical company or clinical research organization ideally in drug safety area.
- Strong Knowledge of medical and pharmacovigilance terminologies e.g. MedDRA
- Knowledge in Pharmacovigilance business processes and computerized systems
- Strong technical knowledge in database technology, query and reporting tool
- Knowledge in quality insurance for regulated computerized systems
- Good Business intelligence knowledge (development of listings and metadata)
- Good analytical skills, able to understand problems and present solutions toward business partners
- Good communication and listening skills, team player and change oriented
- Fluent in both written and spoken English
- Relevant working/residency permit or Swiss/EU-Citizenship required