Pharmacovigilance Product Specialist Role Summary
The Pharmacovigilance Product Specialist acts as a strategic liaison between business users, regulatory teams, and IT to ensure 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. The specialist will oversee end-to-end product roadmaps, ensure alignment with business needs, and drive platform upgrades, integrations, and compliance.
* Product Ownership & Roadmap
* Own and manage the PV product roadmap, ensuring alignment with business priorities.
* Oversee platform maintenance, rebuilding, and tech stack upgrades (e.g., cloud migration).
* Stay updated on latest pharmacovigilance and product technology trends.
* 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
* Oversee 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 & Quality
* Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
* Review 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.
Key Responsibilities: Pharmacovigilance Product Specialist will lead cross-functional teams to develop and implement pharmacovigilance systems and workflows, ensuring compliance with regulatory requirements and industry best practices.
Requirements: To be successful in this role, you should have experience in pharmacovigilance, regulatory compliance, and technology, with a strong understanding of product ownership and cross-functional collaboration.
Benefits: As a Pharmacovigilance Product Specialist, you will have opportunities for professional growth and development, working with a talented team to drive innovation and excellence in pharmacovigilance systems and workflows.