Job Opportunity:
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The Pharmacovigilance Product Analyst plays a vital role in ensuring accurate, compliant, and efficient adverse event reporting.
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This position combines strong product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance, and technology. The analyst will oversee end-to-end product roadmaps, ensure alignment with business needs, and drive platform upgrades, integrations, and compliance.
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* Product Ownership & Roadmap
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* Oversight of PV product roadmap, ensuring alignment with business priorities.
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* Platform maintenance, rebuilding, and tech stack upgrades (e.g., CloudX → KCloud migration).
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* Stay updated on latest pharmacovigilance and product technology trends.
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* Cross-Functional Collaboration
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* Work closely with Business, Infrastructure, and Leadership teams to plan/manage product releases, downtime, incidents, and upgrades.
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* Serve as the key liaison across regulatory, clinical operations, QA, and IT functions.
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* System Integration & Compliance
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* Oversight of safety system integrations (Argus, ArisG, Veeva Vault Safety) ensuring accurate data flow and reporting.
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* Ensure Argus acts as the central system, receiving case data from call centers, flowing through safety systems, and reaching regulatory authorities with compliance documentation.
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* Support signal detection and reporting in line with global compliance and regulatory standards.
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* Monitoring, Debugging & Quality
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* Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
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* Review logs and system access for issue resolution.
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* Collaborate with QA for system quality checks, validation, and signal monitoring.
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* Analysis & Documentation
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* Gather and analyze requirements for PV systems and workflows.
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* Document processes, data flows, and system functionalities related to adverse event reporting.
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* Support validation and user acceptance testing.
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* Provide user training, support, and knowledge sharing.
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Requirements:
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1. Bachelor's degree in Life Sciences, Pharmacy, Information Technology, or related field.
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2. Strong experience as a Product Analyst or Business Analyst in a regulated environment.
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3. Proven knowledge of pharmacovigilance processes and regulatory requirements.
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4. Hands-on experience with PV safety systems such as Argus, ArisG, Veeva Vault Safety.
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5. Strong analytical, problem-solving, and documentation skills.
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6. Excellent communication and stakeholder management abilities.
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Essential Skills:
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* Familiarity with AWS (for RCA/debugging), Cloud/SaaS platforms.
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* Experience with JIRA for incident/release management.
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* Experience with validation and UAT in regulated environments.