Description
We are looking for a
Observational Study Scientist (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Place: in Basel-Country
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Supports Epidemiologists or Associate Director/Director, Observational Studies Scientists in writing study synopses, protocols, Case Report Form content, Health Authority reports, Final study reports, and related documents
- Observational Studies, responsible for Data Quality Review plan and implementation of scientific/medical review of data
- Develops expertise and scientific knowledge in assigned therapeutic areas
- For Observational studies and overall Study Project Team deliverables, develop and implement study related communication and newsletters
- For Observational studies conducted across affiliates, responsible for training of new project team
- Members, affiliate based staff and Clinical Research Associates (CRAs) in collaboration with Post Approval Operations, Global Medical Affairs
- Lead Epidemiology & Observational Studies Team Standard Operating Procedures (SOPs) and processes development, including Data Quality Review process
- Cross-functional collaboration/network with all relevant stakeholders/contributors, mainly Epidemiology, Biostatistics, Operations, Clinical Development Data Management, Global Drug Regulatory Affairs, Global Drug Safety, Global Medical Affairs and Affiliates
- Accountable for working with Global Scientific Information to update public registers/databases
Your qualifications
- Preferably Life sciences degree or other degree (e.g. business, chemistry, engineering) acceptable, if associated with appropriate pharmaceutical experience
- Pharma/biotech experience in clinical or observational studies, with demonstrated achievements and experience of working independently
- Good knowledge of observational studies methodology, guidelines, quality standards and current regulatory requirements e.g. Good Pharmacoepidemiology Practices, Good Pharmacovigilance Practices, European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
- Flexibility, ability to work under pressure
- Attention to detail and quality
- Strong interpersonal skill and the ability to work as part of a team, including remote teams
- Ability to work under limited supervision
- Good command of written and spoken English
Skills:
- R&D scientist