Job Description
The Pharmacovigilance Product Analyst will act as a strategic liaison between business stakeholders, regulatory teams, and IT, ensuring pharmacovigilance systems and workflows enable accurate, compliant, and efficient adverse event reporting.
This role combines strong product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance, and technology.
The incumbent will oversee the PV product roadmap, ensuring alignment with business priorities. They will be responsible for platform maintenance, rebuilding, and tech stack upgrades, staying updated on the latest pharmacovigilance and product technology trends.
The position requires close collaboration with cross-functional teams to plan and manage product releases, downtime, incidents, and upgrades. The successful candidate will serve as the key liaison across regulatory, clinical operations, QA, and IT functions.
They will oversee safety system integrations, ensuring accurate data flow and reporting. The Argus system will act as the central system, receiving case data from call centers, flowing through safety systems, and reaching regulatory authorities with compliance documentation.
The successful candidate will perform monitoring and debugging for system issues, review AWS logs and system access for issue resolution, and collaborate with QA for system quality checks, validation, and signal monitoring.
They will gather and analyze requirements for PV systems and workflows, document processes, data flows, and system functionalities related to adverse event reporting, and support validation and user acceptance testing (UAT).