Pharmacovigilance Product Analyst Role Overview
The Pharmacovigilance Product Analyst acts as a strategic liaison between business stakeholders, regulatory teams, and IT.
This role ensures that pharmacovigilance systems and workflows enable accurate, compliant, and efficient adverse event reporting.
Key Responsibilities:
* Product Ownership & Roadmap: Own and manage the PV product roadmap to ensure 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.
* Analysis & Documentation: Gather and analyze requirements for PV systems and workflows. Document processes, data flows, and system functionalities related to adverse event reporting.
Successful candidates will hold a Bachelor's degree in Life Sciences, Pharmacy, Information Technology, or related field, along with strong experience as a Product Analyst or Business Analyst in a regulated environment.