Pharmacovigilance Product Analyst
The Pharmacovigilance Product Analyst will act as a strategic 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.
The analyst will oversee end-to-end product roadmaps, ensure alignment with business needs, and drive platform upgrades, integrations, and compliance.
Main Responsibilities:
* Product Ownership & Roadmap
* Own and manage the PV product roadmap, ensuring alignment with business priorities.
* Oversee platform maintenance, rebuilding, and tech stack upgrades.
* 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 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.
* Monitoring, Debugging & Quality
* Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
* Review AWS logs and system access for issue resolution.
* Analysis & Documentation
* Gather and analyze requirements for PV systems and workflows.
* Document processes, data flows, and system functionalities related to adverse event reporting.
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.