Job Description
This role combines strong product ownership responsibilities with deep domain expertise in pharmacovigilance regulatory compliance and technology ensuring accurate compliant and efficient adverse event reporting.
Key Responsibilities
* Product Ownership Roadmap: Own and manage the PV product roadmap ensuring alignment with business priorities oversee platform maintenance rebuilding and tech stack upgrades cloudx → kcloud migration stay updated on latest pharmacovigilance and product technology trends aws genai saas solutions.
* Cross-Functional Collaboration: Work closely with business infrastructure and leadership teams to plan/manage product releases downtime incidents and upgrades serve as the key liaison across regulatory clinical operations QA and IT functions.
* System Integration Compliance: Oversight of safety system integrations argus arisg veeva vault safety ensuring accurate data flow and reporting ensure argus acts as the central system receiving case data from call centers flowing through safety systems and reaching regulatory authorities with compliance documentation support signal detection and reporting in line with global compliance and regulatory standards fda ema mhra gxp cfr.
* 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 support validation and user acceptance testing UAT provide user training support and knowledge sharing.