Drug Safety &
Pharmacovigilance
Management
Harmon Analytics delivers specialist pharmacovigilance, medical coding, and regulatory compliance services—empowering life-science organisations to meet global safety obligations with precision and confidence.
A Specialist PV &
Compliance Partner
Founded by pharmacovigilance professionals with decades of industry experience, Harmon Analytics provides a lean, agile alternative to large-scale CROs. We bring enterprise-grade expertise without the overhead.
From standalone coding projects to full safety database migrations and AI-enabled automation programmes, we scale to your needs—whether you are a startup navigating first-in-human trials or a global MAH managing complex post-market obligations.
Get in touchPragmatic & Nimble
We deploy quickly, adapt to your processes, and keep bureaucracy minimal so safety timelines are never compromised.
Collaborative Delivery
We work as an extension of your team, embedding specialist knowledge into your existing workflows seamlessly.
Vendor-Independent
Platform-agnostic advice means we recommend only what is truly right for your organisation, not a vendor agenda.
Our Service Portfolio
Four integrated service lines covering the full spectrum of pharmacovigilance operations and regulatory compliance.
Automation & AI in Pharmacovigilance
Harness the power of natural language processing and machine learning to accelerate narrative generation, literature surveillance, signal detection, and case triage—reducing manual effort while improving consistency.
- NER for adverse event extraction
- Automated literature screening
- Signal detection dashboards
- Case narrative generation
- BI reporting & analytics
MedDRA & WHODrug Coding
Expert medical coding services ensuring compliance with the latest MedDRA and WHODrug dictionaries, underpinned by CMC-certified coders and robust quality management.
- MedDRA LLT, PT, HLT & SOC coding
- WHODrug C & B3 coding
- AE, Medical History & Indication coding
- Verbatim normalisation & standardisation
- Coding convention development & governance
- Dictionary version upgrades
- Query management & resolution
- Batch coding for retrospective data
CMC Certified Professionals
All our coders hold current CMC certification and participate in continuous professional development aligned with MSSO and Uppsala Monitoring Centre guidance.
Quality Control Framework
Double-blind coding, inter-rater reliability checks, and structured QC workflows ensure first-pass accuracy rates above 98%.
Dictionary Version Management
We manage the full upgrade cycle—impact assessment, re-coding, reporting—to keep your safety database current without operational disruption.
Coding Convention Development
We create, review, or update company coding conventions aligned with ICH M1, EMA, FDA, and PMDA guidance to ensure global regulatory alignment.
Process & Technology Consulting
Strategic PV consulting spanning system implementation, process optimisation, and audit readiness—delivered by practitioners with hands-on regulatory experience.
- PV system gap assessments
- SOP & work instruction development
- Audit & inspection readiness
- PSMF creation & maintenance
- Signal detection methodology
- Risk management (RMP / REMS)
- Regulatory submission support
- PV agreement (PVA) management
- Vendor qualification & oversight
- Training programme design
Gap Assessment & Remediation
Systematic evaluation of your PV system against ICH E6(R2), EMA GVP modules, and FDA 21 CFR Part 312/314, with prioritised remediation roadmaps.
Audit & Inspection Readiness
Mock audits, CAPA management, and pre-inspection preparation to ensure your organisation is always inspection-ready.
PSMF & PVA Management
End-to-end authoring and maintenance of Pharmacovigilance System Master Files and PV Agreements in line with current regulatory expectations.
Technology Selection & Validation
Vendor-independent safety system selection, UAT planning, CSV/GAMP5 validation, and go-live support for Argus, ARISg, and cloud-native platforms.
Safety Database Administration
Fully managed pharmacovigilance operations—from day-to-day case processing and database administration to complex E2B migrations and BI reporting.
- Oracle Argus Safety
- ARISg (Relsys)
- Veeva Vault Safety
- CEPTU Safety
- Oracle AERS / FAERS
- Gateway configuration & testing
- E2B(R3) / E2B(R2) conversion
- EMA EVWEB submissions
- FDA ESG gateway setup
- PMDA & CDSCO reporting
ICSR Processing & Follow-Up
Timely case receipt, triage, data entry, narrative writing, medical review coordination, and follow-up management to meet global expedited and periodic reporting deadlines.
Database Migration & Validation
Full-cycle migration projects from legacy platforms—data mapping, validation scripts, parallel runs, and CSV packages compliant with GAMP5.
BI Reporting & Analytics
Custom Power BI and Tableau dashboards delivering real-time KPIs—case processing metrics, coding quality, signal trends, and regulatory submission status.
Periodic Safety Reporting
PSUR, PBRER, DSUR, and IND Annual Report authoring and coordination, including aggregate signal evaluation and benefit-risk narrative support.
AI & NLP in Pharmacovigilance
Purpose-built machine learning and NLP solutions that accelerate PV workflows, reduce manual effort, and surface insights from unstructured data at scale.
- Named Entity Recognition (NER)
- AE & drug entity extraction
- Literature surveillance automation
- Case narrative generation
- Duplicate detection algorithms
- Sentiment & seriousness classification
- Multilingual document processing
NER & Information Extraction
Transformer-based NER models trained on pharmacovigilance corpora to extract adverse events, suspect drugs, patient demographics, and outcomes from free-text sources.
Literature Surveillance
Automated screening of PubMed, Embase, and grey literature with relevance scoring, deduplication, and workflow integration into your safety database.
Signal Detection Dashboards
Interactive dashboards integrating disproportionality statistics (ROR, PRR, BCPNN) with visualised signal timelines and regulatory context.
BI & Operational Analytics
End-to-end analytics pipelines connecting your safety database, coding, and submission data into unified Power BI / Tableau environments for operational oversight.
The Harmon
Advantage
We combine deep domain expertise with operational agility to deliver pharmacovigilance outcomes that make a measurable difference to your compliance posture and patient safety commitments.
Day-One Productivity
Our specialists are industry practitioners—they understand your systems, regulations, and pressures from day one, eliminating the ramp-up time typical of large consultancies.
Global Reach
Serving clients across ICH regions—EU, US, Japan, India—with in-depth knowledge of FDA, EMA, PMDA, and CDSCO regulatory frameworks.
Vendor Independent
We work across all major safety platforms and have no affiliate relationships with software vendors, ensuring our recommendations serve your interests alone.
Quantifiable Outcomes
We set measurable objectives upfront and track progress against them—coding accuracy rates, case processing timelines, system uptime, and regulatory submission compliance.
Request a Consultation
Reach out to discuss your pharmacovigilance needs. We respond within one business day.
Ghaziabad Office
We work with CROs, MAHs, sponsors, and technology vendors. If you are interested in a strategic partnership, use the form to get in touch.