Pharmacovigilance Product Analyst
The role of the Pharmacovigilance Product Analyst is to act as a strategic liaison between business users, regulatory teams, and IT. This ensures that pharmacovigilance systems and workflows enable accurate, compliant, and efficient adverse event reporting.
Key Responsibilities
* Product Ownership & Roadmap
* Manage the pharmacovigilance product roadmap to ensure alignment with business priorities.
* Oversee platform maintenance, rebuilding, and tech stack upgrades.
* Stay 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.
* Serve as the key liaison across regulatory, clinical operations, QA, and IT functions.
* System Integration & Compliance
* Ensure safety system integrations are accurate and compliant.
* Support signal detection and reporting in line with global compliance and regulatory standards.
* Monitoring, Debugging & Quality
* Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
* Collaborate with QA for system quality checks, validation, and signal monitoring.
* Analysis & 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.
Requirements
* 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.
Tools & Technologies
* PV systems: Argus, ArisG, Veeva Vault Safety.