Key role in bridging business, regulatory and IT teams to ensure accurate, compliant and efficient adverse event reporting.
Combining strong product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance and technology.
* Product Ownership & Roadmap
* Manage end-to-end product roadmaps ensuring alignment with business priorities.
* Oversee platform maintenance, rebuilding and tech stack upgrades (e.g., CloudX → KCloud migration).
* Stay updated on latest pharmacovigilance and product technology trends (AWS, GenAI, SaaS solutions).
Cross-functional collaboration for release planning, downtime, incidents and upgrades. Serve as key liaison across regulatory, clinical operations, QA and IT functions.
Seamless system integrations (Argus, ArisG, Veeva Vault Safety) for accurate data flow and reporting.
Support signal detection and reporting according to global compliance standards (FDA, EMA, MHRA, GXP, CFR). Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps and data discrepancies.
Document processes, data flows and system functionalities related to adverse event reporting. Gather and analyze requirements for PV systems and workflows.
Provide user training, support and knowledge sharing.