Job Title: Pharmacovigilance Product Analyst
Act as a strategic liaison between business users, regulatory teams, and IT to ensure pharmacovigilance systems and workflows enable accurate, compliant, and efficient adverse event reporting.
This role combines strong product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance, and technology.
* Key Responsibilities:
* Product Ownership & Roadmap
* Manage the PV product roadmap to align with business priorities.
* Oversee platform maintenance, rebuilding, and tech stack upgrades.
* Stay updated on latest pharmacovigilance and product technology trends.
* Cross-Functional Collaboration
* Collaborate 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
* Oversee safety system integrations ensuring accurate data flow and reporting.
* Ensure Argus acts as the central system for case data, safety systems, and regulatory authorities with compliance documentation.
* Support signal detection and reporting in line with global compliance and regulatory standards.
* 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.
Requirements
* 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.
Desirable 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.