Senior Drug Safety Manager (m/w/x) | Frankfurt | Pharma
Our client is a global with an absolute interesting portfolio based on biologics. With almost 2000 workers globally our client covers pre-clinical and clinical development to production and worldwide marketing.
These products are specifically used to help people with serious and often chronic diseases to return to a normal life.
What will your tasks as Drug Safety Manager be?
- Preparation and review of safety-relevant clinical studies Creation and revision of departmental and cross-interface work instructions and other quality management documents
- Preparation of periodic safety reports (PSUR/ PBRER/DSUR), RMPs and signal management
- Creation and review of safety-relevant clinical reports (DSUR, CSR), clinical expert statements and corresponding chapters in approval dossiers
- 2nd line Medical information
- Medical Review
- Medical Doctor
- Minimum 4 years' experience in global / local Pharmacovigilance OR PV experience in a higher federal authority or scientific institution
- Good knowledge of European and international regulatory requirement in the PV field
- German: fluent in spoken and written, English: fluent
Is this role interesting for you and you want to know more about it?
Do not hesitate to contact me immediately.
I am looking forward to your call.
My contact details:
- Email: firstname.lastname@example.org
- Tel: 0049 (0) 89/21093938 (direct dial)