Description
Drug Safety Specialist (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Main 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
Main 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
Main advantages:
- A highly motivated team and an open way of communication
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Cigdem Aydin
Referencenumber:
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