Pharmacovigilance Product Specialist
The Pharmacovigilance Product Specialist plays a pivotal role in ensuring the smooth operation of adverse event reporting systems, acting as a liaison between business users, regulatory teams, and IT. This strategic position combines product ownership responsibilities with domain expertise in pharmacovigilance, regulatory compliance, and technology.
Key Responsibilities:
* Manage the PV product roadmap to ensure alignment with business priorities.
* Oversee platform maintenance, rebuilding, and tech stack upgrades to maintain system efficiency.
* Stay updated on the latest pharmacovigilance and product technology trends to drive innovation.
Cross-Functional Collaboration:
* Work closely with Business, Infrastructure, and Leadership teams to plan and manage product releases, downtime, incidents, and upgrades.
* Serve as the key liaison across regulatory, clinical operations, QA, and IT functions.
System Integration & Compliance:
* Oversee safety system integrations to ensure accurate data flow and reporting.
* Ensure Argus acts as the central system for receiving case data, flowing through safety systems, and reaching regulatory authorities with compliance documentation.
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.
Analysis & Documentation:
* Gather and analyze requirements for PV systems and workflows.
* Document processes, data flows, and system functionalities related to adverse event reporting.
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.
Required Skills:
* Familiarity with AWS (for RCA/debugging), Cloud/SaaS platforms.
Essential Requirements:
* Expertise in pharmacovigilance, regulatory compliance, and technology.
* Proven track record in managing PV product roadmaps and overseeing platform maintenance.
* Strong analytical and problem-solving skills.