About the Role
As a strategic liaison between business users, regulatory teams, and IT, you will ensure pharmacovigilance systems and workflows enable accurate, compliant, and efficient adverse event reporting.
The ideal candidate will combine strong product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance, and technology.
Key responsibilities include:
* Product Ownership & Roadmap: Own and manage the PV product roadmap, ensuring alignment with business priorities.
* Cross-Functional Collaboration: Work closely with Business, Infrastructure, and Leadership teams to plan/manage product releases, downtime, incidents, and upgrades.
* System Integration & Compliance: Oversee safety system integrations (Argus, ArisG, Veeva Vault Safety) ensuring accurate data flow and reporting.
* Monitoring, Debugging & Quality: Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
Requirements
A bachelor's degree in Life Sciences, Pharmacy, Information Technology, or a related field is required.
* Strong experience as a Product Analyst or Business Analyst in a regulated environment is essential.
* Proven knowledge of pharmacovigilance processes and regulatory requirements is necessary.
* Familiarity with AWS (for RCA/debugging), Cloud/SaaS platforms is desired.
Tools & Technologies
* PV systems: Argus, ArisG, Veeva Vault Safety