Description
We are looking for a
Clinical Safety Expert (m/f)
Referenz: -en
Beginn: asap
Dauer: 12 MM
Ort: in Berlin
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Managing death and adverse event reporting in compliance with applicable regulatory standards and company's internal requirements
- Case Management in the Clinical Safety database
- Reviewing and triaging clinical trial deaths and adverse events (AEs) including serious adverse events (SAEs)
- Working in the company's Clinical Safety team located around the world (Clinical Operations, Data Management, Quality Assurance and Regulatory Affairs)
Ihre Qualifikation
- University degree in the field of pharmacy, etc.
- Experiences in the field of clinical safety
- Ability to work effectively on cross-functional teams
- Broad knowledge of GCP reporting guidelines
Skills:
- Drug safety manager
Keywords: clinical safety pharmacy pharmacist adverse events database