Job Overview
This is a challenging opportunity for an experienced professional to join our company in the role of Pharmacovigilance Product Analyst.
The successful candidate will act as a strategic liaison between business users, regulatory teams, and IT, ensuring pharmacovigilance systems and workflows enable accurate, compliant, and efficient adverse event reporting.
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.
* Product Ownership & Roadmap
* Oversight of PV product roadmap, ensuring alignment with business priorities.
* Platform maintenance, rebuilding, and tech stack upgrades (e.g., CloudX → KCloud migration).
* Stay updated on latest pharmacovigilance and product technology trends (AWS, GenAI, SaaS solutions).
* 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
* Oversight of safety system integrations (Argus, ArisG, Veeva Vault Safety) ensuring accurate data flow and reporting.
* Ensure Argus acts as the central system, receiving case data from call centers, flowing through safety systems, and reaching regulatory authorities with compliance documentation.
* Support signal detection and reporting in line with global compliance and regulatory standards (e.g., FDA, EMA, MHRA, GXP, CFR).
* Monitoring, Debugging & 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 & 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.
Key Qualifications:
* Bachelor's degree in Life Sciences, Pharmacy, Information Technology, or 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 such as Argus, ArisG, Veeva Vault Safety.
* 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.
About Our Company:
We are a leading provider of cloud-based software solutions for the life sciences industry. Our mission is to provide innovative and effective solutions that meet the evolving needs of our clients.
],