Supporting the maintenance of current pharmacovigilance safety system (ARGUS). and other GPS systemsAbility to work flexible hours supporting users in different time zones. May need to work in shifts as needed / assigned.Collaboration with IT teams, Vendor resources to plan and implement system related changes (Routine changes and Change Requests).Initiation, review and notification of routine changes to pharmacovigilance safety system.Review and analysis of user requirements prior to submission and implementation, participate in validation activities as required.Perform periodic review of administrator data including but not limited to user access, company product dictionary and Safety Data Exchange agreements.Ensure that changes made to the databases are controlled through the change control process.Ensure proposed changes to the Pharmacovigilance Safety System are reviewed and validated with GPS functional area prior to processing for implementationResponsible for creating, verifying and tracking complex change requests, including updates to reporting rules, product lists and code lists.Drive consistent interpretation of system related conventions, specifications, and definitions when making any configuration changesMaintain and manage SharePoint sites used for tracking systems requests (Routine changes and Change Requests)Take initiative to recognize, prioritize & escalate potential safety / compliance issuesServe as a backup for the equivalent Data Analyst role as needed to generate complete and accurate reports from the pharmacovigilance safety systemQualifications :
- Excellent technical, analytical and problem solving skills as it pertains to Pharmacovigilance database systems
- Strong knowledge of Pharmacovigilance system (e.g. ARISg, ARGUS) with good understanding of the database structure and application architecture
- Strong technical system skills (e.g. Word processing, Excel spreadsheets, Powerpoint, Sharepoint, SQL and Databases)
- Strong knowledge of pharmacovigilance terminology and understanding of data entry conventions
- Excellent oral and written communication skills with attention to detail
- Excellent interpersonal skills that encourage teamwork
- Ability to work independently under strict deadlines and changing priorities
- Ability to multitask and prioritize changing workload for self
- Broad knowledge / understanding of relevant ICH guidelines, as well as FDA and EU Regulations
- Problem Solving- Identify priorities and key issues in complex situations, and formulate and execute issue resolution with minimal assistance
Skills Required
Databases, Pharmacovigilance, Systems Management, Data Management