Safety Data Analyst
- Experience Level
- Experienced (non-manager)
- Maintains Configuration documentation for the Argus System
- Participate in the configuration of new programs on the Argus System
- Support the change management for existing programs on the Argus System
- Configure ad-hoc reports out of the Argus System
- Support the Safety Data Managers, Safety Data Associates and Safety Scientists when required.
- Provide support and ensure collaboration during the upgrade process, i.e. installation, validation and implementation of the Argus System version.
- Minimum of 2 years Safety Data experience
- Minimum of 2 years in Clinical Research experience preferred
- Computer science knowledge preferred, but not mandatory
- Fluent in English; additional languages a plus, but not required
- Drug safety regulated environment working experience preferred
- Strong computer skills with Argus experience; i.e. Case Processing
- Good knowledge of GDP
Specific Job Duties:
- Safety database administration
- Actively participate in the management of the requirements analysis of Safety Database
- Configuration activities on project specific Argus configurations
- Support and train to safety database end users and sponsors, if applicable
- Support the Safety Data Managers/Safety Scientists/Safety Data Associates
- Ability to effectively communicate with both technical and non-technical individuals
- Inspect and resolve safety database problems quickly and effectively
- Be aware of and maintain the workflow and timelines for each project
- Interact with staff, clients or partners to ensure case information is adequate and accurate
- Interact with the Management/Safety Scientists/Safety Data Associates to discuss ongoing projects
- Ensure filing of all documents and organize all filing systems
- Participate in and contribute to team meetings
- Other duties assigned by management.
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
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