**Job Details**:
We have an exciting opportunity for a Senior Clinical Safety Specialist to join our team in Norway!
The role will include:
- Data entry and QC of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature; reporting of ICSRs to the competent authorities
- Support in the generation, processing, documenting, and tracking of follow-up requests
- Screening and documentation of scientific literature regarding safety relevant publications
- Assist in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports), risk management plans and signal detection reports
- Interact with customers as needed (e.g. meetings, client visits, day to day case processing, etc.)
- PSMF maintenance
- Contribute to/review QA documents such as Working Instructions, SOPs, Working Proc...