Beschreibung
We are looking for a
Drug Safety Specialist (50%) (m/f)
Reference: -en
Start: 04/17
Duration: 12 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Set up and maintain safety process for assigned clinical studies (e.g. safety management plan, reconciliation)
- Case processing activities from clinical studies and post-marketing experience
- Manage updates and revisions of safety data exchange agreements (SDEA) and be involved in the preparation of new SDEAs
- Preparation of aggregate safety reports (DSUR, PSUR)
- Be involved in updates of PV SOPs and of processes at safety CRO
- Maintenance of the pharmacovigilance system master file (PSMF)
- Ensure that all adverse event reports are processed according to SOPs
- Filing and archiving of relevant safety information as required
Your qualifications
- Advanced degree in Life Sciences (Minimum Bachelor)
- Solid experience in pharmacovigilance/drug safety, ideally at headquarters level
- Used to interact with other departments (e.g. Clinical Development, Regulatory Affairs)
- Fluent in English (verbal and written), other languages are of advantage (e.g. French, German, Italian)
- Working knowledge of EU pharmacovigilance requirements for investigational and marketed compounds
- MS Word, Excel, PowerPoint skills
- Good written and verbal communication skills
Skills:
- Drug safety assistant