Job Description
The Pharmacovigilance Product Analyst role requires a strategic liaison between business users, regulatory teams, and IT. This individual will ensure 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.
Duties:
* Oversee end-to-end product roadmaps, ensuring alignment with business needs.
* Drive platform upgrades, integrations, and compliance.
* Stay updated on latest pharmacovigilance and product technology trends.
Collaboration and Communication:
* 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 and Compliance:
* Oversee 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.
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.
Qualifications
To be successful in this role, you should have:
* 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
You should have:
* 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
You will work with:
* PV systems: Argus, ArisG, Veeva Vault Safety.