Specialist, Global PV & Epidemiology

Summary

Boehringer Ingelheim is a global pharmaceutical company focused on discovering, developing, and delivering products to patients and customers. The Specialist, Global PV & Epidemiology delivers quantitative pharmacovigilance analytics, regulatory reporting support, and digital initiatives for global safety surveillance. The role supports signal detection and evaluation, regulatory compliance, committee reporting, and automation and artificial intelligence initiatives across Global Pharmacovigilance.

Responsibilities

• Performs all company business in accordance with all regulations and company policies and procedures
• Immediately reports noted/observed violations to management
• Demonstrates high ethical and professional standards with all business contacts to maintain company's excellent reputation in the community
• 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
• 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
• 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
• 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
• 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

Skills

• 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
• 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
• Must be legally authorized to work in the United States without restriction
• Must be 18 years of age or older
• Epidemiology, pharmacovigilance, drug safety, or related field preferred
• Experience with FDA, EMA and/or other animal health regulatory agencies is preferred
• Knowledge of adverse event signal management processes is a plus
• Familiarity with MedDRA and/or VeDDRA terminology is a plus

Qualifications

Must Haves

• 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
• 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
• Must be legally authorized to work in the United States without restriction
• Must be 18 years of age or older

Nice to Haves

• Epidemiology, pharmacovigilance, drug safety, or related field preferred
• Experience with FDA, EMA and/or other animal health regulatory agencies is preferred
• Knowledge of adverse event signal management processes is a plus
• Familiarity with MedDRA and/or VeDDRA terminology is a plus

Benefits

• Opportunity for employees to collaborate internationally
• Visibility and the opportunity to directly contribute to the company's success
• Support to foster a healthy working environment
• Meaningful work
• Mobility
• Networking
• Work-life balance