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Quantitative Signal Analytics & Signal Management:

Supports/Generates and maintains monthly quantitative signal detection and signal management workflows. Performs data review and triage activities to identify observations requiring advancement to signal validation. Generates base data/reports as required for further analysis (line listings, two-period comparisons). Performs batch analyses and seasonality evaluations as required to support safety assessments. Collaborates with PV product responsible persons, veterinarians, epidemiologists, and safety scientists to interpret analytical findings. Develops and maintains standardized analytical outputs and documentation supporting signal governance activities. Ensures analyses are inspection-ready, reproducible, and appropriately documented according to GxP.

Signal Evaluation Committee Reporting:

Drafts monthly Signal Evaluation Committee meeting reports and minutes. Documents committee discussions, decisions, actions, and outcomes. Coordinates committee review and decision documentation. Generates final reports in accordance with established governance procedures. Maintains archival records supporting regulatory and inspection requirements according to GxP and GDP. Requests for

PV Information Support:

Conducts batch analysis activities supporting Requests for PV Information (RPI). Extracts, analyzes, and summarizes relevant safety data from pharmacovigilance databases and reporting systems. Prepares clear and accurate analytical summaries. Ensures timely delivery of responses while maintaining data quality and compliance requirements.

Regulatory Reporting & Annual Statements:

Generates and coordinates annual and periodic pharmacovigilance statements/reports required by global health authorities.

Prepares Annual Statement reports for:

European Medicines Agency (EMA), Israel Ministry of Health, United Kingdom VMD, etc. Supports quality control, reconciliation, and submission-readiness activities. Maintains documentation and compliance records according to GxP.

PV Innovation, Automation & Systems Excellence:

Proactively identifies opportunities to improve efficiency through automation, digitalization, and AI-enabled solutions. Partners with stakeholders to design, test, and implement innovative PV process improvements. Supports development of automated analytics, reporting tools, dashboards, and workflow solutions. Contributes to strategic initiatives involving artificial intelligence and advanced analytics within Global PV. Develops expertise in designated PV systems and tools. Requirements Bachelor's degree in Life Sciences, Epidemiology, Data Science, Public Health, Statistics, or related discipline required. Minimum of two (2) years' experience working in a regulatory/compliance (GxP) environment. Epidemiology, pharmacovigilance, drug safety, or related field preferred. Strong English skills (written and oral) Strong working knowledge of Microsoft Office products. Experience with Power BI, SQL, SAS, R, Python, or equivalent analytical tools. Must have strong organizational and time management skills to work with diverse cultures and departments. Ability to work in a team environment or experience working in a project environment. Attention to detail quality focused and strong technical and problem-solving skills. Experience performing quantitative analysis and/or data interpretation. Experience working with large datasets and reporting tools. Experience with AI, automation, workflow tools, or digital transformation initiatives. Knowledge of adverse event signal management processes is a plus. Experience with FDA, EMA and/or other animal health regulatory agencies is preferred. Familiarity with MedDRA and/or VeDDRA terminology is a plus.

Eligibility Requirements :

Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. 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Find & Apply For Clinical Data Systems Specialist Jobs in Athens, Georgia

Specialist, Global PV & Epidemiology

Clinical Data Associate