About the Role
As a Pharmacovigilance Product Analyst, you will play a pivotal role in bridging the gap between business users, regulatory teams, and IT. This position combines strategic product ownership with deep domain expertise in pharmacovigilance, regulatory compliance, and technology.
Key Responsibilities:
* Product Ownership Roadmap Management: Ensure alignment with business priorities, oversee platform maintenance, rebuilding, and tech stack upgrades, such as cloud migration and staying updated on the 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, serving as a key liaison across regulatory, clinical operations, QA, and IT functions.
* System Integration and Compliance: Oversee safety system integrations, ensuring accurate data flow and reporting, support signal detection and reporting in line with global compliance and regulatory standards.
* Monitoring, Debugging, and 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, collaborate with QA for system quality checks, validation, and signal monitoring.
* Analysis and 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.
Qualifications:
* Bachelor's degree in life sciences, pharmacy, information technology, or a 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.
* Strong analytical, problem-solving, and documentation skills, excellent communication and stakeholder management abilities.
Required Skills:
* Familiarity with AWS for RCA debugging, cloud SaaS platforms.
* Experience with JIRA for incident release management.
* Experience with validation and UAT in regulated environments.
Tools and Technologies:
* PV systems, Argus, ArisG, Veeva Vault Safety.