Senior Pharmacovigilance Systems Specialist
1 semana atrás
About UsWe are a company that specializes in pharmacovigilance solutions.Our team is looking for a skilled Product Analyst to join our ranks.The ideal candidate will have experience working with pharmacovigilance systems, regulatory requirements, and PV safety systems.They will be responsible for ensuring accurate data flow and reporting, as well as staying up-to-date on the latest pharmacovigilance and product technology trends.Key ResponsibilitiesManage the PV Product Roadmap: Ensure alignment with business priorities by overseeing platform maintenance, rebuilding, and tech stack upgrades.Lead Platform Maintenance: Rebuild and upgrade platforms to ensure efficient adverse event reporting.Stay Current on Trends: Stay updated on the latest pharmacovigilance and product technology trends.Collaborate with Teams: Work closely with Business, Infrastructure, and Leadership teams to plan/manage product releases, downtime, incidents, and upgrades.Liaise with Regulatory Teams: Serve as the key liaison across regulatory, clinical operations, QA, and IT functions.Oversee Safety System Integrations: Ensure accurate data flow and reporting between safety systems.Support Signal Detection: Support signal detection and reporting in line with global compliance and regulatory standards.Monitor System Issues: Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.Analyze Requirements: Gather and analyze requirements for PV systems and workflows.RequirementsBachelor's Degree: A bachelor's degree in Life Sciences, Pharmacy, Information Technology, or related field.Experience: Strong experience as a Product Analyst or Business Analyst in a regulated environment.Knowledge: Proven knowledge of pharmacovigilance processes and regulatory requirements.Skillset: Hands-on experience with PV safety systems such as Argus, ArisG, Veeva Vault Safety.Aptitude: Strong analytical, problem-solving, and documentation skills.Communication: Excellent communication and stakeholder management abilities.SkillsFamiliarity with AWS (for RCA/debugging), Cloud/SaaS platforms.Experience with JIRA for incident/release management.Experience with validation and UAT in regulated environments.
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