Global PV & Epidemiology Analytics Specialist

Boehringer Ingelheim; Athens (GA); On-site; USD 110,000 - 150,000; Full time

Job summary

Boehringer Ingelheim in the United States is seeking a Specialist, Global PV & Epidemiology to deliver quantitative pharmacovigilance analytics, regulatory reporting support, and digital initiatives that strengthen global surveillance activities.

The role supports signal detection, safety governance, and data-driven analyses, collaborating with PV teams to ensure inspection-ready documentation and compliance across GxP processes.

Qualifications

• Bachelor's degree in Life Sciences, Epidemiology, Data Science, Public Health, Statistics, or related discipline required.
• Minimum of two years’ experience in regulatory/compliance (GxP) environment.
• Strong English skills (written and oral).
• Experience with Power BI, SQL, SAS, R, Python, or equivalent analytical tools.

Responsibilities

• Performs company business in accordance with regulations and company policies.
• Immediately reports noted/observed violations to management.
• Demonstrates high ethical standards with all business contacts.
• Supports/Generates and maintains monthly quantitative signal detection and signal management workflows.
• Performs data review and triage activities for signal validation.
• Generates base data/reports for analyses (line listings, two-period comparisons).
• Collaborates with PV product teams, veterinarians, epidemiologists, and safety scientists.
• Develops and maintains standardized analytical outputs for signal governance.
• Ensures analyses are inspection-ready and documented per GxP.
• Drafts monthly Signal Evaluation Committee reports/minutes.
• Documents committee discussions, decisions, actions, outcomes.
• Coordinates committee review documentation.
• Generates final reports per governance procedures.
• Conducts batch analysis supporting Requests for PV Information (RPI).
• Extracts, analyzes, and summarizes relevant safety data from PV systems.
• Prepares clear analytical summaries and timely delivery.
• Generates and coordinates regulatory PV statements/reports for EMA, UK VMD, etc.
• Supports quality control, reconciliation, and submission-readiness.
• Maintains documentation per GxP.
• Proactively identifies automation, digitalization, and AI opportunities in PV.
• Partners with stakeholders to design, test, implement PV improvements.
• Supports development of automated analytics, dashboards, workflows.
• Contributes to AI and advanced analytics initiatives.
• Develops expertise in designated PV systems and tools.

Skills

Regulatory compliance

Data analysis

Team collaboration

Strong English communication

Education

Bachelor's degree in Life Sciences or related discipline

Tools

Power BI

SQL

SAS

R

Python

Microsoft Office

Job description

Boehringer Ingelheim in the United States is seeking a Specialist, Global PV & Epidemiology to deliver quantitative pharmacovigilance analytics, regulatory reporting support, and digital initiatives that strengthen global surveillance activities.

The role supports signal detection, safety governance, and data-driven analyses, collaborating with PV teams to ensure inspection-ready documentation and compliance across GxP processes.