Job Description:
The Pharmacovigilance Product Analyst plays a pivotal role in bridging the gap between business users, regulatory teams, and IT to ensure pharmacovigilance systems and workflows facilitate accurate and compliant adverse event reporting.
By combining product ownership with in-depth domain expertise in pharmacovigilance, regulatory compliance, and technology, this analyst oversees end-to-end product roadmaps, ensures alignment with business needs, and drives platform upgrades, integrations, and compliance.
* Own and Manage PV Product Roadmap: Ensure seamless alignment with business priorities.
* Oversee Platform Maintenance: Rebuild and upgrade tech stack as needed.
* Cross-Functional Collaboration: Work closely with Business, Infrastructure, and Leadership teams to plan and manage product releases, downtime, incidents, and upgrades.
* System Integration & Compliance: Oversee safety system integrations to ensure accurate data flow and reporting.
* Monitoring, Debugging & Quality: Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
* Analysis & Documentation: Gather and analyze requirements for PV systems and workflows.
Required Skills and Qualifications:
The ideal candidate has strong experience as a Product Analyst or Business Analyst in a regulated environment.
Familiarity with AWS (for RCA/debugging), Cloud/SaaS platforms is required.