Job Summary:
We are seeking a highly skilled Pharmacovigilance Product Analyst to join our team. This is a unique opportunity to combine strong product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance, and technology.
The successful candidate will own and manage the PV product roadmap, ensuring alignment with business priorities. They will oversee platform maintenance, rebuilding, and tech stack upgrades.
* Product Ownership & Roadmap: Develop and maintain the PV product strategy, working closely with cross-functional teams to ensure alignment with business objectives.
* Cross-Functional Collaboration: Collaborate with Business, Infrastructure, and Leadership teams to plan and manage product releases, downtime, incidents, and upgrades.
* System Integration & Compliance: Oversee safety system integrations, ensuring accurate data flow and reporting. Ensure that Argus acts as the central system, receiving case data from call centers, flowing through safety systems, and reaching regulatory authorities with compliance documentation.
* Monitoring, Debugging & Quality: Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies. Review AWS logs and system access for issue resolution. Collaborate with QA for system quality checks, validation, and signal monitoring.
* Analysis & Documentation: Gather and analyze requirements for PV systems and workflows. Document processes, data flows, and system functionalities related to adverse event reporting.
Required Skills:
* Proficiency in AWS (for RCA/debugging), Cloud/SaaS platforms.
* Experience with JIRA for incident/release management.