The Drug Safety System Specialist is a support role for the Drug Safety Systems team that will focus on tasks related to the management and business utilization of the drug safety database, drug safety data and reports. Responsibilities include:
• Business support activities related to the safety database including understanding and documenting business requirements and configuration management.
• Managing and facilitating the process for generation of aggregate safety reports to ensure compliance with global regulatory requirements.
• Collaborating with IT, internal key stakeholders and external business partners to coordinate the appropriate deliverables for aggregate safety reports, drug safety business requirements and data requests.
• Recommending technical solutions and reports to Drug Safety colleagues by analyzing the needs of the business and aligning with available tools and data
Demonstrated proficiency and experience:
• Bachelor's degree required
• Ability to successfully lead meetings comprised of internal & external resources (up to 35 attendees) including executive level attendees
• Proficient in interpreting regulatory requirements and effectively conveying meaning to educate and resolve discrepancies amongst a diverse audience
• Business and data analysis skills in pharmaceutical or related space
• Business requirements gathering and specification development
• Creating test scenarios and executing test protocols
• Strong understanding of Microsoft Office tools including Word, Excel, Power Point and Visio; Excel skills to including pivot tables and functions
• Time management skills with ability to handle time sensitive deadlines and quickly pivot when unexpected events or changes present themselves
• Excellent communication (written and oral) and collaboration with technical and non-technical audiences
• 2+ years in in the pharmaceutical industry preferably in one of the following areas: Drug Safety, Clinical Operations, or Regulatory Affairs
Desired proficiency and experience:
• Knowledge of global aggregate report regulations and guidance (e.g. PSUR/PBRER, DSUR, PADER)
• Direct experience with systems and data that support Drug Safety (e.g., Argus, ARISg)
• SQL Skills
• Report development using business intelligence tools with structured data sets
Source: Job Diva – Job Listing