Pharmacovigilance Product Analyst
2 semanas atrás
Job Title: Pharmacovigilance Business Analyst (PharmaCov BA) Duration : 6 to 12 months with possible extension or FTE conversion after 6 months.Location: Remote (Brazil) Job Title: Pharmacovigilance Product Analyst / Business Analyst Location: Brazil The Pharmacovigilance Product Analyst (PV Product Analyst / BA) will act as a strategic liaison between business users, regulatory teams, and IT, ensuring pharmacovigilance (PV) 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.The analyst will oversee end-to-end product roadmaps, ensure alignment with business needs, and drive platform upgrades, integrations, and compliance.Roles and Responsibilities: Product Ownership & Roadmap Own and manage the PV product roadmap, ensuring alignment with business priorities.Oversee platform maintenance, rebuilding, and tech stack upgrades (e.g., CloudX ? KCloud migration).Stay updated on latest pharmacovigilance and product technology trends (AWS, GenAI, SaaS solutions).Cross-Functional Collaboration Work closely 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 (Argus, ArisG, Veeva Vault Safety) ensuring accurate data flow and reporting.Ensure Argus acts as the central system, receiving case data from call centers, flowing through safety systems, and reaching regulatory authorities with compliance documentation.Support signal detection and reporting in line with global compliance and regulatory standards (e.g., FDA, EMA, MHRA, GXP, CFR).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.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.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.Required 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.Tools & Technologies: PV systems: Argus, ArisG, Veeva Vault Safety.
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Pharmacovigilance Business Analyst
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