Nazil Wasim

Senior Business Quality Analyst with over three years of experience as implementation consultant in pharmacovigilance domain as a Reporting SME. Proven ability to deliver effective solutions in both team-oriented and independent environments. Expertise in leading client implementations, requirement gathering, workshop delivery, and managing multiple projects simultaneously.

• Pharmacovigilance Domain: In-depth knowledge of safety systems such as Argus, ArisG, Safety, and PV case management
• Reporting and Compliance Expertise: Expertise in tools like PV case management, PV Repros, PV Central, and PV Quality of RxLogix for case management and compliant reporting
• Client implementation: Expertise in implementing pharmacovigilance products from RxLogix
• Workshop Delivery: Conducted numerous client workshops on PV case management, PV reports, PV central, and PV quality
• Ad hoc report Creation: Skilled in generating ad hoc reports tailored to business requirements
• Aggregate Reports: A deep understanding of PADER, PBRER, and DSUR report requirements
• SQL Knowledge: Proficient in writing SQL queries for validation
• Business/Functional Analysis: Extensive experience in analyzing, discussing, and documenting business, functional, and application requirements, with documentation expertise in Requirement Specification Documents, Configuration Specification Documents, RTM, and Validation Summary Reports
• Client Interaction: Skilled in interacting with clients to gather and author business, functional, and non-functional requirements, and improvements
• Application Configuration: Expertise in application installations, configurations, and business process mappings for drug safety and pharmacovigilance clients

Pharmacovigilance: Aggregate Reporting

ICSR