Drug Safety Manager

Apsida Life Science have partnered with a leading research company to present the following role

Drug Safety Case Manager

1. Contract Role of 12 months

Summary

The candidate will be responsible for completing case processing: triaging, data entry, coding of AEs, narrative writing, quality control and submission of expediting AE reports to health authorities Additionally, the candidate will perform case prioritization according to relevant Standard Operating Procedures to ensure timely submission of expediting reports to regulatory authorities and will identify missing information and initiation of follow up requests in collaboration with Drug Safety Physician

Candidate requirements

1. University degree in life sciences (pharmacy, nurse) or equivalent education in health-related field
2. Adverse Event (AE) reporting experience
3. At least 5 years' experience in safety or clinical data management
4. Knowledge of medical terminology and general understanding of disease processes
5. SOP experience
6. Solid knowledge of coding thesauri and medical/drug dictionaries
7. Good knowledge of the EU and US safety reporting requirements
8. Fluency in English, both verbal and written

Immediate Hire