Job Title: Pharmacovigilance Product AnalystWe are seeking a highly skilled and experienced Pharmacovigilance Product Analyst to join our team.This is a unique opportunity to work on pharmacovigilance systems and workflows, ensuring accurate and compliant adverse event reporting. As a key liaison between business users, regulatory teams, and IT, you will play a crucial role in driving platform upgrades, integrations, and compliance.The ideal candidate will have strong product ownership responsibilities, deep domain expertise in pharmacovigilance, regulatory compliance, and technology, as well as excellent communication and stakeholder management abilities.Roles and Responsibilities:Product Ownership & RoadmapOwn and manage the PV product roadmap, 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 CollaborationWork 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 & ComplianceOversee 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 (e.g., FDA, EMA, MHRA, GXP, CFR).Monitoring, Debugging & QualityPerform 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 & DocumentationGather 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.Requirements:Bachelor's degree in Life Sciences, Pharmacy, Information Technology, or related field.Strong experience as a Product Analyst or Business Analyst in a regulated environment.Proven knowledge of pharmacovigilance processes and regulatory requirements.Hands-on experience with PV safety systems such as Argus, ArisG, Veeva Vault Safety.Strong analytical, problem-solving, and documentation skills.Excellent communication and stakeholder management abilities.Skills:Familiarity with AWS (for RCA/debugging), Cloud/SaaS platforms.Experience with JIRA for incident/release management.Experience with validation and UAT in regulated environments.