What are the responsibilities and job description for the Drug Safety Specialist position at Fusion Life Sciences Technologies LLC?
Job Title: Patient Safety Systems Principal Analyst
Location: Boston, MA (Need locals)
Durations: 12 Months
GENERAL POSITION SUMMARY
The Patient Safety Systems Principal Analyst serves as the business administrator for the GPS systems including the Global Safety Database (Oracle Argus). This position is responsible for providing oversight and management of the administration, maintenance and business function operational support of databases, with responsibility for more complex assignments.
KEY RESPONSIBILITIES
· Design, configuration and implementation of advanced/complex system upgrades
· Create complex custom and ad hoc reports to meet growing business needs.
· Work closely with GPS management and business users to understand requirements and recommend solutions.
· Daily troubleshooting and problem resolution for end users
· Lead ongoing application administration tasks, coordination of the change control process to ensure timely development, testing and release of updates
· Project Management responsibility for GPS projects as assigned
· Work/Collaborate with Data, Technology and Engineering (DTE) teams
· May supervise other GPS Safety Systems staff
· Other projects and activities requested of department management.
EDUCATION AND EXPERIENCE
· Bachelor’s degree in computer sciences or related scientific engineering fields
· Minimum 5 years safety systems experience is required or the combination of education and experience
· Proficiency in MS Word, Excel and PowerPoint.
· Advanced Oracle Argus Safety systems experience (configuration and operational support) is required
· Advanced knowledge of Reporting Tools (RxLogix PV Reports, Toad/Toad Data Point, OBIEE or Power BI)
· Create complex custom/aggregate and ad-hoc reports to meet growing business needs.
· Strong presentation, communication (verbal and written) and interpersonal skills
· High proficiency in Oracle SQL
· Substantial experience in hands-on analysis and application support in a Windows O/S application environment supporting multi-tiered application architecture to include web based application clients
· Strong knowledge of GCP, FDA, EMA regulatory requirements as they apply to pharmacovigilance and working knowledge of safety database, and system life-cycle concepts
· Experience in the pharmaceutical or biotechnology industry