One of our clients located in Germany (Darmstadt) has launched a thrilling opportunity as Global Drug Safety Consultant (M/F/D).
- Have a strong experience in Drug Safety - Phase I to IV
- Have a very good English knowledge - written and spoken
Then, you might be the candidate we are looking for !
As Global Drug Safety Consultant, you support TMF activities for company sponsored (Cladribine Studies) - Phase I to IV.
This includes several responsibilities :
- You review the safety sections of study related documents (e.g. Clinical Trial Protocol, Drug Safety Manual/Safety Processing Plan, Trial Oversight Plan, SAE reconciliation plan, Trial Oversight Plan) including documents for Cladribine IST studies
- You communicate about the clinical studies within GPS (e.g. clinical study status)
- You contribute to the definition and implementation of clinical trial safety related activities in alliance with relevant partners/service providers
- You ensure the alignment of guidelines and processes related to clinical trial safety management with existing GPS processes
- You support post-Marketing activities (e.g. Global Literature Surveillance)
- You have a strong experience in Drug Safety - Phase I to IV
- You have a very good English knowledge - written and spoken
+32 10 68 53 30