Pharmacovigilance Product Analyst
3 semanas atrás
Job Overview Pharmacovigilance Business Analyst (PharmaCov BA) – Duration: 6 to 12 months, with possible extension or FTE conversion after 6 months. Remote (Brazil). Pharmacovigilance Product Analyst / Business Analyst – Remote Brazil. Roles and Responsibilities 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). 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. 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 (FDA, EMA, MHRA, GXP, CFR). 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. 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. #J-18808-Ljbffr
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