Pharmacovigilance · Ontario, Canada

The only Canadian consultancy built end-to-end around pharmacovigilance.

Senior techno-functional specialists covering the full PV lifecycle — safety systems, analytics, migration, and AI development — built to hold up under audit.

Fluent in the tools your safety team already runs on
ArgusARISgMedDRAPower BITableauOBIEE
What we hand over
Custom PBRER, DSUR &
CIOMS II reports
Signal detection &
RMP outputs
Argus upgrade &
change control support
E2B(R3) configuration &
testing
IQ/OQ/PQ packages &
traceability matrix
MedDRA & WHODrug
upgrade impact assessment
Expedited clocks
7 / 15-day
ICSR format
E2B(R3) & (R2)
Validation
GAMP 5 · Part 11
WHAT WE DO

Five disciplines, one dedicated PV team.

Safety Systems Consulting
Senior techno-functional experts, embedded across your safety system's full lifecycle.
Techno-functional PV SMEs
Safety vendor management
System upgrade consulting
Safety system configuration & E2B
MedDRA & WHO Drug impact assessment
Training & SOP development
+5 more capabilities Learn more
Data Analytics & Visualization
Audit-ready reporting and automated dashboards, built on the tools you already run.
Argus Safety, Insight & Mart reporting
ARISg & LSMV reporting
Operational, risk & compliance reports
Audit & inspection reports
Power BI, Tableau & Spotfire dashboards
Automated report delivery
+4 more capabilities Learn more
Data Migration
Clean, fully validated transitions between safety systems, checked at every step.
Argus, ARISg, LSMV & clinical systems
E2B and non-E2B migration
Acquisition & divestiture support
Structured & unstructured sources
Data accuracy & integrity validation
Data verification utility
+3 more capabilities Learn more
CSV Consulting
Computer system validation for safety systems — planned, executed, and documented to survive inspection.
CSV validation plans & strategy
URS, FRS & design specifications
IQ / OQ / PQ protocols & reports
Requirements traceability matrices
Deviation investigation & CAPA
Risk assessment & GAMP 5
+5 more capabilities Learn more
AI Development
Agentic AI and custom apps for drug safety, shipped with validation evidence.
Automated case intake
MedDRA coding support
Signal triage & monitoring
Literature surveillance
Aggregate report drafting
Custom PV apps & agents
Validation evidence included Learn more
HOW WE WORK

A proven path from assessment to go-live.

01
Assess
We audit your current safety systems and processes against GVP and Health Authority expectations to find the gaps that matter.
02
Configure
We configure, upgrade, or customize Argus, ARISg, and your reporting stack to match validated requirements.
03
Validate & migrate
Every change is tested before go-live — data accuracy, integrity, and E2B compliance checked at each step.
04
Support & optimize
Post go-live, we train your team, monitor performance, and keep operations audit-ready as regulations evolve.
OUR STORY

Get to know us

Merakee BI Analytics Ltd. is the only Canadian-based firm built exclusively around Pharmacovigilance Consulting. Our senior techno-functional consultants are fluent in the safety systems — Argus, ARISg, and beyond — that keep patients safe.

From system configuration and reporting to regulatory compliance and risk management — we're fully committed to giving clients the support their safety operations depend on.

Mississauga, Ontario, Canada
100% dedicated to Pharmacovigilance
Techno-functional delivery team
Flexible: project, staff-aug, or full program
CLIENT REFERENCES

What safety leaders say after working with us.

Verbatim recommendations from safety and regulatory leaders, attributed by title at their request.

I highly recommend Merakee BI for PV reporting and safety database needs. I have had the pleasure of working with Merakee BI for my company's Argus safety database. They are innovative and proactively suggest changes to optimize my team's use of Argus. Merakee BI is expert at programming customized reports and outputs to support signaling, aggregate reports, RMP and regulatory responses. They handle the change control process for the db and are the SME that interfaces with our Vendor for larger IT projects such as Argus upgrades. They are very much an integral part of my Safety team and are proactive at identifying and solving issues, with an individualized approach that takes in consideration cost and practicality. This type of 360 degree thinking isn't usually found in vendor services. Merakee BI takes care of my Safety team like it's their own. Their expertise and engagement have significantly contributed to the success of my team.

Vice President, Head of Global Patient Safety

Merakee BI has provided an invaluable support system for Ironwood's Global Patient Safety Group. Sachin and his team have supported a significant Argus upgrade as well as multiple operational updates, generated and validated several custom reports including custom PBRER, DSUR, CIOMS and Signal Detection Reports, and provide day-to-day support for the global safety database, working closely with our hosting vendor. They are essential members of the Safety team who collaborate with Quality and IT on a regular basis, which led to improved efficiency of our overall systems-related procedures. I highly recommend Merakee BI to support your pharmacovigilance needs.

Senior Vice President, Regulatory Affairs

Sachin and his team at Merakee BI PV Consulting are excellent safety database administrators! They excel at being able to manage database hosting vendors, database programming and report design/generation, and translating very technical database and programming jargon into operational terms making for very effective collaborations with cross-functional teams. I highly recommend for all your safety database oversight and management needs.

Safety / PV Scientist

Ready to strengthen your safety systems?

Talk to a PV specialist about your Argus, ARISg, or LSMV environment.

Get in touch
Merakee BI

Dedicated PV consulting for safety systems, analytics, migration, and AI development.

CONTACT
600 Matheson Blvd W Unit 5, Mississauga, ON L5R 4C1, Canada
647-854-1079
info@merakeebi.com
© 2020–2026 Merakee BI Analytics Ltd. Mississauga, Ontario, Canada
Pharmacovigilance · Ontario, Canada

The only Canadian consultancy built end-to-end around pharmacovigilance.

Senior techno-functional specialists covering the full PV lifecycle — safety systems, analytics, migration, and AI development — built to hold up under audit.

Fluent in the tools your safety team already runs on
ArgusARISgMedDRAPower BITableauOBIEE
What we hand over
Custom PBRER, DSUR &
CIOMS II reports
Signal detection &
RMP outputs
Argus upgrade &
change control support
E2B(R3) configuration &
testing
IQ/OQ/PQ packages &
traceability matrix
MedDRA & WHODrug
upgrade impact assessment
Expedited clocks
7 / 15-day
ICSR format
E2B(R3) & (R2)
Validation
GAMP 5 · Part 11
WHAT WE DO

Five disciplines, one dedicated PV team.

Safety Systems Consulting
Senior techno-functional experts, embedded across your safety system's full lifecycle.
Techno-functional PV SMEs
Safety vendor management
System upgrade consulting
Safety system configuration & E2B
MedDRA & WHO Drug impact assessment
Training & SOP development
+5 more capabilities Learn more
Data Analytics & Visualization
Audit-ready reporting and automated dashboards, built on the tools you already run.
Argus Safety, Insight & Mart reporting
ARISg & LSMV reporting
Operational, risk & compliance reports
Audit & inspection reports
Power BI, Tableau & Spotfire dashboards
Automated report delivery
+4 more capabilities Learn more
Data Migration
Clean, fully validated transitions between safety systems, checked at every step.
Argus, ARISg, LSMV & clinical systems
E2B and non-E2B migration
Acquisition & divestiture support
Structured & unstructured sources
Data accuracy & integrity validation
Data verification utility
+3 more capabilities Learn more
CSV Consulting
Computer system validation for safety systems — planned, executed, and documented to survive inspection.
CSV validation plans & strategy
URS, FRS & design specifications
IQ / OQ / PQ protocols & reports
Requirements traceability matrices
Deviation investigation & CAPA
Risk assessment & GAMP 5
+5 more capabilities Learn more
AI Development
Agentic AI and custom apps for drug safety, shipped with validation evidence.
Automated case intake
MedDRA coding support
Signal triage & monitoring
Literature surveillance
Aggregate report drafting
Custom PV apps & agents
Validation evidence included Learn more
HOW WE WORK

A proven path from assessment to go-live.

01
Assess
We audit your current safety systems and processes against GVP and Health Authority expectations to find the gaps that matter.
02
Configure
We configure, upgrade, or customize Argus, ARISg, and your reporting stack to match validated requirements.
03
Validate & migrate
Every change is tested before go-live — data accuracy, integrity, and E2B compliance checked at each step.
04
Support & optimize
Post go-live, we train your team, monitor performance, and keep operations audit-ready as regulations evolve.
OUR STORY

Get to know us

Merakee BI Analytics Ltd. is the only Canadian-based firm built exclusively around Pharmacovigilance Consulting. Our senior techno-functional consultants are fluent in the safety systems — Argus, ARISg, and beyond — that keep patients safe.

From system configuration and reporting to regulatory compliance and risk management — we're fully committed to giving clients the support their safety operations depend on.

Mississauga, Ontario, Canada
100% dedicated to Pharmacovigilance
Techno-functional delivery team
Flexible: project, staff-aug, or full program
CLIENT REFERENCES

What safety leaders say after working with us.

Verbatim recommendations from safety and regulatory leaders, attributed by title at their request.

I highly recommend Merakee BI for PV reporting and safety database needs. I have had the pleasure of working with Merakee BI for my company's Argus safety database. They are innovative and proactively suggest changes to optimize my team's use of Argus. Merakee BI is expert at programming customized reports and outputs to support signaling, aggregate reports, RMP and regulatory responses. They handle the change control process for the db and are the SME that interfaces with our Vendor for larger IT projects such as Argus upgrades. They are very much an integral part of my Safety team and are proactive at identifying and solving issues, with an individualized approach that takes in consideration cost and practicality. This type of 360 degree thinking isn't usually found in vendor services. Merakee BI takes care of my Safety team like it's their own. Their expertise and engagement have significantly contributed to the success of my team.

Vice President, Head of Global Patient Safety

Merakee BI has provided an invaluable support system for Ironwood's Global Patient Safety Group. Sachin and his team have supported a significant Argus upgrade as well as multiple operational updates, generated and validated several custom reports including custom PBRER, DSUR, CIOMS and Signal Detection Reports, and provide day-to-day support for the global safety database, working closely with our hosting vendor. They are essential members of the Safety team who collaborate with Quality and IT on a regular basis, which led to improved efficiency of our overall systems-related procedures. I highly recommend Merakee BI to support your pharmacovigilance needs.

Senior Vice President, Regulatory Affairs

Sachin and his team at Merakee BI PV Consulting are excellent safety database administrators! They excel at being able to manage database hosting vendors, database programming and report design/generation, and translating very technical database and programming jargon into operational terms making for very effective collaborations with cross-functional teams. I highly recommend for all your safety database oversight and management needs.

Safety / PV Scientist

Ready to strengthen your safety systems?

Talk to a PV specialist about your Argus, ARISg, or LSMV environment.

Get in touch
Merakee BI

Dedicated PV consulting for safety systems, analytics, migration, and AI development.

CONTACT
600 Matheson Blvd W Unit 5, Mississauga, ON L5R 4C1, Canada
647-854-1079
info@merakeebi.com
© 2020–2026 Merakee BI Analytics Ltd. Mississauga, Ontario, Canada