Senior Safety Surveillance Associate (f/m) (Germany, Munich)We are looking for a talented professional with broad experience in Safety Surveillance in the Life Science industry.
- Data entry, maintaining, processing and tracking and of safety cases and reports from clinical sites, spontaneous reporters and other entities according to the Company’s good documentation procedures
- Ensures and files case documentation and provides the information to the Safety Lead
- Monitors and files case documentation, electronic Safety mailbox, receives documents, and disseminates cases and provides the information to the Safety lead.
- Analysis and review of the Safety report and data entry of case information into the safety database (including case creation, initial database entry, and entry of follow-up information for safety reports)
- Collaboration with Safety Leads to create, distribute, and track investigator notification letters and IRB/EC notifications as required by government regulations
- Identification of missing data, creation of standard queries for missing or inconsistent data and evaluation of finalized queries
- Assistance with audit preparation and ad hoc projects
- Bachelor’s degree in nursing (B.S.N.), Registered Nurse (R.N.), Doctor of Pharmacy, Health Science degree or other related field of study
- 2+ years Safety Surveillance experience in a CRO environment
- Good understanding of medical terminology and of GCPs, ICH guidelines and global drug safety and drug development process and regulations
- Understanding safety databases and/ or ability to learn safety database software and related software functionality
- Detail orientated, structures, deadline orientated and ability to keep an overview
- Intermediate level proficiency in Microsoft Word, Excel, and Outlook; basic proficiency in PowerPoint and effective verbal and writing skills
- Excellent English skills (written and oral)