Medical Safety Advisor PART TIME (m/w/x) | Frankfurt | Pharma
Our client is a global company providing plasma protein products and bio therapeutic medicinal products. The products are mainly used in the areas of clinical immunology, haematology and intensive care medicine. These products are specifically used to help people with serious and often chronic diseases to return to a normal life. Furthermore, they are active in the specialised field from preclinical and clinical development to production and global marketing.
What will your tasks as Medical Safety Advisor be?
- Advice for doctors, license partners and colleagues in Germany and abroad on drug safety issues
- Creation and revision of departmental and cross-interface work instructions and other quality management documents
- Creation and review of safety-relevant clinical reports (DSUR, CSR), clinical expert statements and corresponding chapters in approval dossiers
- Creation of periodic safety update reports (PSUR/ PBRER) and risk management plans
- Signal management and ongoing benefit-risk assessment of assigned projects/products
- Medical Doctor or Pharmacist
- Clinical Experience in haematology, paediatrics, or intensive care medicine
- Mind. 3 year's 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
- Independent working style, structured person who is able to communicate medical issues to different stakeholders in a target group-oriented manner
- German: fluent in spoken and written, English: fluent
They will offer you?
- Unlimited contract
- 60% Remote
- 30 holiday days
- attractive benefits package
My contact details:
- Email: email@example.com
- Tel: 0049 (0) 89/26 20 09 25 (direct dial)
- Xing: https://www.xing.com/profile/Marlene_Inderhees/cv
- LinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/
I'm looking forward to speaking with you.