This position reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and Patient Safety (PPS) organization’s Global PV Strategy Management Office. The PPS organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand, and communicate the safety profile of our drugs to protect patients worldwide.
- Handling documentation for the affiliate query process.
- Performing reconciliation tasks (SPORT, TOPICS, COSMOS, weekly surveillance).
- Generates and supports reporting process (Close-out Reports, Vendor Qualification, Service Provider Training, Ad-Hoc and metrics).
- Effectively prioritizes and manages own time to complete assigned tasks.
- Demonstrates functional and technical knowledge and skills to perform daily quality control checks of the PV Partnership Inventory against contracts entered and aggregate safety reports and signal assessments for post-marketing Epi study protocols, study reports, and progress reports. Clearly and succinctly communicates information to customers verbally and in writing pertaining to non-compliance entries in databases.
- Demonstrates and applies high level of customer service to both internal and external customers Utilizes judgment skills to identify issues that impact the workflow.
- Uses rigorous logic and methods to solve difficult problems.
- Identifies gaps and areas that need improvement and communicates and/or implements recommendations/changes.