Advanced Post-Marketing Surveillance & Pharmacovigilance Analytics

Ensuring drug safety after market approval requires sophisticated statistical analysis and regulatory expertise.

As a specialized pharmacovigilance consultant, I help pharmaceutical companies, regulatory agencies, and research organizations navigate the complexities of post-marketing surveillance and safety monitoring.

Whether you’re managing spontaneous reporting systems, conducting signal detection analyses, or preparing regulatory submissions, my statistical expertise ensures your pharmacovigilance programs meet the highest standards for patient safety and regulatory compliance.

Comprehensive Pharmacovigilance Analytics Services

Transform your safety data into actionable insights that protect patients and support regulatory compliance.

My end-to-end pharmacovigilance analytics services help organizations build robust drug safety monitoring systems and extract meaningful patterns from complex safety databases.

Study Design & Safety Monitoring Plans

Develop robust frameworks for comprehensive post-marketing surveillance programs.

  • Design active surveillance studies using electronic health records and claims data
  • Establish signal detection methodologies for spontaneous reporting systems
  • Create statistical sampling plans for periodic safety update reports (PSURs)
  • Develop risk minimization strategies with measurable safety endpoints
  • Plan long-term safety monitoring protocols for special populations
  • Design comparative safety studies across therapeutic alternatives

Advanced Signal Detection & Data Mining

Implement cutting-edge statistical methods to identify safety signals in large datasets.

  • Automated signal detection using disproportionality analysis and Bayesian methods
  • Machine learning algorithms for pattern recognition in adverse event data
  • Statistical screening of spontaneous reporting databases for emerging safety concerns
  • Time-to-event analysis for safety signal validation
  • Multi-database signal detection across different data sources
  • Artificial intelligence applications for pharmacovigilance automation

Regulatory Compliance & Reporting

Navigate complex regulatory requirements with statistical precision and documentation.

  • Prepare statistical sections for periodic safety update reports (PSURs)
  • Conduct benefit-risk assessments using quantitative methodologies
  • Generate regulatory-compliant safety analyses for health authority submissions
  • Develop statistical approaches for risk evaluation and mitigation strategies (REMS)
  • Create audit-ready documentation for pharmacovigilance systems
  • Support regulatory inspections with robust statistical evidence

Real-World Safety Data Integration

Harness the power of real-world evidence for comprehensive safety monitoring.

  • Electronic health records surveillance for adverse drug reactions
  • Integration of claims data, EHR data, and spontaneous reports
  • Longitudinal safety analysis using linked healthcare databases
  • Comparative safety studies across different patient populations
  • Hospital-based safety monitoring using administrative data
  • Social media and patient-reported outcome integration for safety signals

Specialized Safety Analytics

Apply advanced statistical methods to complex pharmacovigilance challenges.

  • Causal inference methods for establishing drug-event relationships
  • Confounding adjustment in observational safety studies
  • Missing data handling in safety databases
  • Survival analysis for time-to-adverse event studies
  • Bayesian approaches for safety signal evaluation
  • Meta-analysis of safety data across multiple studies
  • Propensity score matching for comparative safety research

Ongoing Analytics Support

Beyond initial implementation, I provide continuous support for your pharmacovigilance operations.

  • Regular safety database reviews and trend analysis
  • Statistical validation of pharmacovigilance workflows
  • Training on advanced analytics methods for safety teams
  • Quality assurance for statistical outputs in safety reports
  • Consultation on emerging safety questions and regulatory changes
  • Development of automated reporting systems for routine safety metrics
Let's Talk

Why Work With Me For Your Pharmacovigilance Needs?

Working with a specialized consultant benefits your organization in many ways.

Time Efficiency

Focus on core drug development activities while I handle complex statistical analyses and regulatory requirements.

Reduced Compliance Risk

Navigate regulatory expectations with confidence through rigorous statistical methods and documentation standards.

Advanced Analytics Capabilities

Access cutting-edge statistical methods including machine learning, causal inference, and big data analytics specifically designed for pharmacovigilance applications.

Actionable Safety Insights

Transform raw safety data into clear, defensible conclusions that support patient safety decisions and regulatory submissions with confidence.

The Pharmacovigilance Analytics Process

My consulting process is designed for regulatory compliance and scientific rigor.

Discovery & Requirements Assessment

We begin with a comprehensive consultation to understand your safety monitoring objectives, data sources, regulatory requirements, and specific pharmacovigilance challenges.

Analytics Strategy & Study Design

Together, we develop a detailed project scope including statistical analysis plans, data integration strategies, and regulatory deliverables. All specifications are documented in a formal Service Proposal with clear timelines and costs.

Data Analysis & Implementation

I execute sophisticated statistical analyses using validated methods, handling complex issues like confounding, missing data, signal validation, and multi-database integration while maintaining full regulatory compliance.

Deliverables & Reporting

I provide comprehensive reports with regulatory-compliant statistical outputs, publication-ready visualizations, detailed methodology documentation, and executive summaries tailored for regulatory submissions and internal stakeholders.

For urgent questions, my on-demand consultation service offers quick, cost-saving solutions.

Book Express Consultation

Case Studies

I worked on large medical datasets to answer causal questions related to epidemiological determinants of disease through complex exposures. Challenges included selection bias, confounding, and missing data. I successfully developed a strategy that gave researchers confidence in their results.
I’ve worked with R&D scientists who were simultaneously running multiple experiments to answer important questions about their cutting-edge products that would have a direct impact on various stakeholders. My role was to help in designing and analyzing the experiments, balancing the conceptual purity of the Design of Experiments theory (DoE) with pragmatic concerns relating to costs and timeline. Most of this work is sealed behind a Non-Disclosure Agreement (NDA) which prevents me from elaborating more.

Don’t Just Take My Word For It…

The positive experiences of my happy collaborators showcased through their glowing testimonials, serve as powerful proof of trustworthiness and the impact of the results I deliver. These testimonials offer real-life examples of how I’ve helped research projects succeed. Here are some of their thoughts:

5/5

"He has a deep understanding of statistics, yet is able to skillfully explain complex concepts to people with little-to-no background in statistics both in French and English."

Elsa Brunet-Ratnasginham

Post-doc, UCSF

5/5

"I had never before worked with a biostatistician who speaks the same language as me! [...] Personally, our collaboration has allowed me to reconcile with statistics."

Manon Nayrac

Post-doc, CRCHUM

5/5

"I highly recommend Justin and his team for your data processing needs in order to have a more robust statistical model than the tests we are accustomed to conducting as biologists!"

Gérémy Sannier

Ph.D candidate, CRCHUM

5/5

"Thanks to him, statistics appeared to me as solutions rather than obstacles."

Mathieu Dubé

Research Associate, CRCHUM

Read Full Collaborator Testimonials
Justin Belair - Causal Inference Expert

My Statistics and Causal Inference Expertise

As a university-level statistics lecturer with a substantial LinkedIn following, scientists from all over the world come to me for my unique combination of academic excellence and practical experience in statistics and causal inference.

I’ve applied causal inference methods in varied settings in both academia and industry: in biomedical sciences such as nephrology, immunology, neuroscience, virology, occupational therapy, epidemiology, dermatology, psychiatry, and oncology; in natural sciences such as agronomy, ecology, and zoology; and social sciences such as communication, and psychology. The list keeps on growing!

I am currently writing an advanced textbook that I hope will give a young generation of academic and industry researches the tools needed to grapple with the complexities of causal inference, and maybe even develop a passion for the subject!

Need expert pharmacovigilance analytics support? From signal detection to regulatory compliance, I offer specialized statistical expertise to strengthen your drug safety monitoring programs and protect patient welfare.

Let's Talk

Tools and Technologies

Statistical Software Excellence

Using industry-standard tools like R, Python, and SAS, I implement validated statistical methods specifically designed for pharmacovigilance applications and regulatory compliance.

Pharmacovigilance Database Integration

I leverage extensive experience with major safety databases including FDA Adverse Event Reporting System (FAERS), EudraVigilance, and proprietary pharmaceutical company databases for comprehensive safety analysis.

Advanced Analytics Platforms

My expertise includes specialized pharmacovigilance software, electronic health record systems, claims databases, and emerging artificial intelligence platforms designed for safety signal detection and risk assessment.

Client Industries Served

My statistical consulting expertise extends beyond specific industries, serving clients in fields ranging from R&D in biotechnology and pharmaceuticals to researchers and Principal Investigators (PI) in academia.