Job Overview:
The Pharmacovigilance Product Analyst will act as a strategic liaison between business stakeholders, regulatory teams, and IT departments, 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. The analyst will oversee end-to-end product roadmaps, ensure alignment with business needs, and drive platform upgrades, integrations, and compliance.
* Key Responsibilities
* Oversight of the PV product roadmap to ensure alignment with business priorities.
* Platform maintenance, rebuilding, and tech stack upgrades (e.g., CloudX → KCloud migration).
* Staying updated on latest pharmacovigilance and product technology trends (AWS, GenAI, SaaS solutions).
* Cross-Functional Collaboration
* Collaboration with Business, Infrastructure, and Leadership teams to plan/manage product releases, downtime, incidents, and upgrades.
* Serving as the key liaison across regulatory, clinical operations, QA, and IT functions.
* System Integration & Compliance
* Overseeing safety system integrations (Argus, ArisG, Veeva Vault Safety) ensuring accurate data flow and reporting.
* Ensuring Argus acts as the central system, receiving case data from call centers, flowing through safety systems, and reaching regulatory authorities with compliance documentation.
* Supporting signal detection and reporting in line with global compliance and regulatory standards (e.g., FDA, EMA, MHRA, GXP, CFR).
* Monitoring, Debugging & Quality
* Performing monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
* Reviewing AWS logs and system access for issue resolution.
* Collaborating with QA for system quality checks, validation, and signal monitoring.
* Analysis & Documentation
* Gathering and analyzing requirements for PV systems and workflows.
* Documenting processes, data flows, and system functionalities related to adverse event reporting.
* Supporting validation and user acceptance testing (UAT).
* Providing user training, support, and knowledge sharing.
About This Role
This position is ideal for individuals who possess a unique blend of technical skills and domain expertise. The successful candidate will be responsible for driving business value through effective product ownership and strategic decision-making.