About the Role
We are seeking a highly skilled Product Analyst to join our team in Pharmacovigilance. The successful candidate will be responsible for acting as a strategic liaison between business users, regulatory teams, and IT.
The role combines strong product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance, and technology.
Key Responsibilities
* Owning and managing the PV product roadmap, ensuring alignment with business priorities.
* Overseeing platform maintenance, rebuilding, and tech stack upgrades.
* Staying updated on latest pharmacovigilance and product technology trends.
Cross-Functional Collaboration
* Working closely with Business, Infrastructure, and Leadership teams to plan/manage product releases, downtime, incidents, and upgrades.
* Serving as the key liaison across regulatory, clinical operations, QA, and IT functions.
System Integration & Compliance
* Overseeing safety system integrations ensuring accurate data flow and reporting.
* Ensuring 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 & Quality
* Performing monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
* Reviewing AWS logs and system access for issue resolution.
Analysis & Documentation
* Gathering and analyzing requirements for PV systems and workflows.
* Documenting 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.
* Proven knowledge of pharmacovigilance processes and regulatory requirements.
Required Skills
* Familiarity with AWS (for RCA/debugging), Cloud/SaaS platforms.
* Experience with JIRA for incident/release management.
Tools & Technologies
* PV systems: Argus, ArisG, Veeva Vault Safety.