Gra Representative Aggregate Safety Reporting
Vor 4 Tagen
**My duties**
- Support departmental therapeutic areas with the management of aggregate safety reports
- Develop regulatory components associated with aggregate safety reporting: IND and BLA annual reports and also DSURs and PSURs
- Own the documentation of the regulatory components of aggregate safety reports
- Ensure GRA engagement in aggregate safety report development and maintenance
- Guarantee execution of aggregate safety report submissions to Health Authorities according to strategy
- Resolve and align internal GRA functions inputs for aggregate safety reports and questions from health Authorities
**My qualifications**
- Experience in the field of Global Regulatory Affairs especially with IND & BLA and also DSURs and PSURs
- Profound experience with the management of aggregate safety reports
- Fluent in English and German
**My benefits**
- Fully remote work possible (service on site might be required occasionally)
- Renowned pharmaceutical company
- Motivated team and innovative working environment
**About Hays**
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**Josephin Rosa Christmann
**Reference number**606499/1
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