What We Have to OfferOur team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations
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.
Tasks and Responsibilities
- 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)
To ApplyIf you are interested in this responsible position with diversified and challenging tasks please apply through E-Mail and let us know your earliest start date and what your desired salary range is.