- Excellent interepersonal communication skills, both written and oral
- Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word)
- Safety database and data entry experience preferred
- Basic understanding of medical and drug terminology preferred
- Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred
- Demontrates initiative, teamwork and accountability
- Demonstrated success working both independently and in collaboration with others
- A quality driven individual with strong attention to detail and accuracy is required
- Strong organizational skills, and ability to adapt to change
- A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strick timelines is required
- Ability to follow guidelines and procedural documents Operations Sets work priorities and direction with input from Manager
- Review, extract and accurately enter AE data from ICSR reports from both investigational and postmarketing products
- Have solid working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports
- Will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate
All your information will be kept confidential according to EEO guidelines.
