Highly Experienced Pharmacovigilance Specialist

Job Overview:The role of Pharmacovigilance Product Analyst is a strategic position that requires a strong understanding of pharmacovigilance processes, regulatory requirements, and technology.About the Role:The successful candidate will act as a liaison between business users, regulatory teams, and IT, ensuring pharmacovigilance systems and workflows enable accurate, compliant, and efficient adverse event reporting.This role combines strong product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance, and technology.Key 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 Collaboration:The ideal candidate will work closely with Business, Infrastructure, and Leadership teams to plan/manage product releases, downtime, incidents, and upgrades.They will serve as the key liaison across regulatory, clinical operations, QA, and IT functions.System Integration & Compliance:The Pharmacovigilance Product Analyst will oversee safety system integrations (Argus, ArisG, Veeva Vault Safety) ensuring accurate data flow and reporting.They will ensure 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:This role involves performing monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.The candidate will review AWS logs and system access for issue resolution and collaborate with QA for system quality checks, validation, and signal monitoring.Analysis & Documentation:The successful candidate will gather and analyze requirements for PV systems and workflows.They will document processes, data flows, and system functionalities related to adverse event reporting and support validation and user acceptance testing (UAT).They will provide user training, support, and knowledge sharing.Qualifications: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.