Job Title: Pharmacovigilance Product Analyst
About the Role:
This is a critical position in our organization, requiring strong product ownership skills and deep domain expertise in pharmacovigilance, regulatory compliance, and technology. The successful candidate will oversee end-to-end product roadmaps, ensure alignment with business needs, and drive platform upgrades, integrations, and compliance.
Responsibilities:
1. Product Ownership & Roadmap:
2. Oversight of PV product roadmap to ensure alignment with business priorities.
3. Maintenance, rebuilding, and tech stack upgrades (e.g., CloudX → KCloud migration).
4. Stay updated on latest pharmacovigilance and product technology trends (AWS, GenAI, SaaS solutions).
5. Cross-Functional Collaboration:
6. Work closely with Business, Infrastructure, and Leadership teams to plan/manage product releases, downtime, incidents, and upgrades.
7. Serve as the key liaison across regulatory, clinical operations, QA, and IT functions.
8. System Integration & Compliance:
9. Oversight of safety system integrations (Argus, ArisG, Veeva Vault Safety) ensuring accurate data flow and reporting.
10. Ensure Argus acts as the central system, receiving case data from call centers, flowing through safety systems, and reaching regulatory authorities with compliance documentation.
11. Support signal detection and reporting in line with global compliance and regulatory standards (e.g., FDA, EMA, MHRA, GXP, CFR).
12. Monitoring, Debugging & Quality:
13. Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
14. Review AWS logs and system access for issue resolution.
15. Collaborate with QA for system quality checks, validation, and signal monitoring.
16. Analysis & Documentation:
17. Gather and analyze requirements for PV systems and workflows.
18. Document processes, data flows, and system functionalities related to adverse event reporting.
19. Support validation and user acceptance testing (UAT).
20. Provide user training, support, and knowledge sharing.
Requirements:
* Strong product ownership skills.
* Deep domain expertise in pharmacovigilance, regulatory compliance, and technology.
* Excellent collaboration and communication skills.
* Able to work in a fast-paced environment.
* Ability to adapt to changing priorities and deadlines.
What We Offer:
We offer a competitive salary and benefits package, opportunities for professional growth and development, and a dynamic work environment.