Beschreibung
- Lausanne area on site work needed
- Reachable by public transport
PV Officer/Drug Safety/Drug Safety Case Manager (m/f/d)
Reference: -en
Start: asap
Duration: 6 MM
Main tasks:
- E-TMF filing for on-going studies and also previous studies
- Transfer of SAE data from a CRO safety database to a clients Safety database
- Ensure the processing of AEs according to the SOPs and study specific Safety Monitoring Plan
- Ensures vendor is in compliance with DPI SOPs and quality requirements for triage of AEs, data entry into the safety database, coding of events and narrative writing
- Perform QC for SUSARs and reports SUSARs to EMA using the Eudravigilance system, to Ethics committees and to investigators
- Ensure reconciliation of safety data between the Clinical and Safety databases in collaboration with our license partners when applicable
- Ensure communication with license partners according to the SDEA : transfer of cases, performs reconciliations and answers to partner’s requests for additional information (queries)
Main qualifications
- Degree in Life Science
- First experience working with Drug Safety Cases
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail
- Willingness to work in a matrix environment and to value the importance of teamwork
- Excellent interpersonal, written and verbal communication skills
- Good IT skills with good industry knowledge
- Team spirit and strong service orientation
- Fluent English
Main advantages:
- Immediate start possible
- Join an innovite growing company
- Pharma leading company
- Being able to both contribute and grow in Drug Safety
- A company with a family like culture
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:
Jadie Ann Vallons
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