Beschreibung
Senior Clinical Safety Officer (m/f/d)
Reference: -en
Start: asap
Duration: limited
Main tasks:
- Manages case processing for clinical trials and electronic reporting to Health Authorities
- Manages the interactions with internal departments as well as vendors, sponsors, commercial partners and CROs in the area of Clinical Safety
- Ensures reconciliation between the clinical and safety database
- Coordinates Development Safety Update Reports (DSURs)
- Writes Safety Management Plans
- Ensures Signal detection activities for products in development as a member of the Safety Assessment Committee
- Ensures the appropriate filing of clinical safety documents in the eTMF
- Implements CAPA changes to update the system and processes
- Creates and maintains local SOPs & Working Instructions
- Collaborates with license partners and ensures maintenance of Pharmacovigilance Agreements and workflow documents for products used in clinical trials with our products in development
- Participates in audits and inspections
- Manages CROs for relevant sub-contracted activities
- Back-up person for other clinical safety officers
Main qualifications
- Degree in Biology, Pharmacist
- Profound experience in clinical safety with good knowledge of EU and US regulations
- Experience in audit and/or inspection and implementation of CAPA changes
- Successful track record in managing external partners
- XEVMPD and Eudravigilance training certificates would be an asset
- Strong experience with a Safety Database
- Solid writing and editorial skills, as well as familiarity with medical terminology
- Experience in Oncology drug development preferred
- Team player, used to work in a matrix organization
- Demonstrate excellent written and verbal communication skills in English and French
Main advantages:
- Dynamic enterprise
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:
Manel Kamelia Sendi
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