Quote of the week:
"Kindness is the language which the deaf can hear and the blind can see."
~ Mark Twain
2/25/14 – Safety Sytems Analyst
Accentuate Staffing is currently recruiting a Safety Systems Analyst for a client of ours in RTP, NC.
- Generate line listings and perform ad hoc queries for GDS
- Generate data for Annual Periodic Reports and Product Reviews
- Perform databases searches in support of white papers and medical inquiries
- Generate regular ad hoc reports; generate and distribute global metrics
- Perform data reconciliation between clinical and safety databases
- Provide local application and hardware support
- Coordinate, integrate, and/or interface with vendor technologies
- Participate in special projects to drive compliance and efficiency improvements
- Oversee data migration and work with partners’ systems representatives to coordinate and resolve issues
- Oversee governance of safety database configuration and coordinate resources accordingly
- Ensure MedDRA and WHODrug licenses are current, to include: performing contract updates and obtaining financial purchase orders
- Engage in troubleshooting activities for reports and line listings utilizing solid pharmacovigilance and systems knowledge
- Bachelor’s Degree in Computer Science, Business, Biological Sciences, etc.
- 8+ years of experience within the Health Care or Life Sciences industry
- 4+ years of experience in Pharmacovigilance
- Experience with Safety Databases; Argus is required and ARISg is preferred
- Ability to work with customers in terms of support, requirement gathering, and training
- Knowledge of FDA GxP regulation and documentation requirements
- Proficient in Microsoft Office