Life Science Product Development Expert
1 semana atrás
Job Overview As a Pharmacovigilance Product Analyst, you will play a pivotal role in ensuring the integrity of pharmacovigilance systems and workflows.
Your responsibilities will encompass ensuring accurate, compliant, and efficient adverse event reporting.This role combines strong product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance, and technology.
You will oversee end-to-end product roadmaps, ensure alignment with business needs, and drive platform upgrades, integrations, and compliance.Product Ownership & Roadmap: Develop and manage the PV product roadmap, aligning it with business priorities.Cross-Functional Collaboration: Work closely with Business, Infrastructure, and Leadership teams to plan/manage product releases, downtime, incidents, and upgrades.System Integration & Compliance: Oversee safety system integrations (Argus, ArisG, Veeva Vault Safety) ensuring accurate data flow and reporting.Monitoring, Debugging & Quality: Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.Analysis & Documentation: Gather and analyze requirements for PV systems and workflows.
Document processes, data flows, and system functionalities related to adverse event reporting.Key Responsibilities: Product Ownership & Roadmap Cross-Functional Collaboration System Integration & Compliance Monitoring, Debugging & Quality Analysis & Documentation 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.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.
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