Description
For my client a internationaly very well-known CRO based in Geneva,Switzerland I am looking for aSafety scientist
Job description:
This position is primarily responsible for supporting all operational functions within the Safety Department including, but not limited to, client interface and deliverables, individual case safety report (ICSR) case processing; assisting with project start-up: process flows; assist with database configuration needs; training and contributing to the development and maintenance of departmental standards (SOPs) and guidelines.
Requirements:
- Health care professional degree
- Comprehensive knowledge of ICH and FDA Regulations and Guidelines both clinical and post marketing
- Knowledge of vaccine and medical device reporting requirements, a plus
- Proficient with computer programs (Safety database, Word, PowerPoint, Excel)
- Knowledge of database management and use of coding dictionaries
- Good communication, interpersonal interaction, project management and organizational skills are essential
- Fluent in English, additional language fluency a plus, but not required
- Ability to multitask with exceptional time management skills
Supervisory Responsibilities:
- Ensure time management and assess quality of work
- Able to provide constructive feedback for performance improvement when appropriate.
Specific Job Duties:
- Assist with the preparation of adverse event reporting plans (AERPs)
- Maintain a listing of all administrative changes and updates
- Ensure all processes as described are operational
- Alert Project Management when activities fall outside SOW
- Process and evaluate AE reports according to the customer's standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality assessment
- Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings
- Assist in the reconciliation of clinical and safety databases.
- Liaise with both internal and external vendors (clients, patients and HCPs)
- Medical review of source documents, coding, data entry, report generation and distribution
- Monitor compliance metrics and ensure appropriate documentation when deficient.
- Assist in evaluation and validation of systems to support safety.
- Other duties as assigned by management
If you are interested in this opportunity feel free to get in touch with me at a.metaj(@)realstaffing.com on and I would be more than happy to provide you with further details. I look forward to hearing from you.