Life Sciences Regulatory Liaison

Pharmacovigilance Product AnalystThis role requires a strategic liaison between business users, regulatory teams, and IT.The ideal candidate will oversee end-to-end product roadmaps, ensuring alignment with business needs and driving platform upgrades, integrations, and compliance.Key Responsibilities:Product Ownership Roadmap: Own and manage the PV product roadmap, ensuring alignment with business priorities.Platform Maintenance and Upgrades: Oversee platform maintenance, rebuilding, and tech stack upgrades, including cloud migration.Stay Updated on Latest Trends: Stay updated on the latest pharmacovigilance and product technology trends, including AWS, GenAI, and SaaS solutions.Cross-Functional Collaboration: Work closely with business infrastructure and leadership teams to plan, manage product releases, downtime incidents, and upgrades.System Integration Compliance: Serve as the key liaison across regulatory, clinical operations, QA, and IT functions to ensure system integration and compliance.Safety System Integrations: Oversee safety system integrations, including Argus, Arisg, and Veeva Vault Safety, ensuring accurate data flow and reporting.Signal Detection and Reporting: Support signal detection and reporting in line with global compliance and regulatory standards, including FDA, EMA, MHRA, GXP, and CFR.Monitoring and Debugging: Perform monitoring and debugging for system issues, including unprocessed cases, reconciliation gaps, and data discrepancies.Collaboration with QA: Collaborate with QA for system quality checks, validation, and signal monitoring.Qualifications:Bachelor's degree in life sciences, pharmacy, information technology, or a 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, and Veeva Vault Safety.Strong analytical problem-solving and documentation skills.Excellent communication and stakeholder management abilities.Required Skills:Familiarity with AWS for RC/debugging cloud/SaaS platforms.Experience with Jira for incident/release management.Experience with validation and UAT in regulated environments.The Pharmacovigilance Product Analyst will act as a strategic liaison between business users, regulatory teams, and IT, ensuring pharmacovigilance PV systems and workflows enable accurate, compliant, and efficient adverse event reporting.