Responsibilities
- Works closely with pharmacovigilance business stakeholders to gather requirements and propose effective technical solutions.
- Generates custom and on-demand reports from the pharmacovigilance safety database using native tools, OBIEE, or SQL queries.
- Builds and verifies aggregated safety reporting outputs.
- Resolves technical issues and responds to user inquiries regarding the safety database.
- Provides support during regular dictionary update cycles.
- Coordinates with the pharmacovigilance safety system vendor for system improvements, troubleshooting, and project execution.
- Helps draft standard operating procedures for the safety database environment.
- Supports internal and third-party audit activities related to the safety database.
- Implements changes to the safety database in compliance with change control policies, including configuration and system updates.
- Configures new tenant environments within the safety database platform.
- Sets up and maintains distribution rule logic in the safety database.
- Leads data migration initiatives, including planning, validation, and documentation to ensure accuracy and completeness.
- Engages with project teams or clients to gather input and confirm deliverable expectations.
- Delivers programming expertise for safety data analysis, custom reporting, and related tasks.
- Takes ownership of project efforts when required, ensuring timely and in-scope delivery.
- Evaluates existing workflows and suggests enhancements for efficiency and effectiveness.
- Oversees task assignments to meet deadlines while maintaining high-quality output.
- Estimates project effort to support bidding and budgeting processes.
Work Arrangement
On-site
