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Pharmacovigilance & Risk Management

A trusted partner for the medicines and medical device industry

Our team is highly quality focused, ensuring patient safety throughout a product’s lifecycle from development phases throughout post-marketing surveillance

Our processes are based on a robust Quality Management System. ISO 9001:2015 accreditation and the integration of industry best practice.

Notably, Commercial Eyes has been inspected by the FDA and the TGA 6 times over the past two years with no critical findings identified. This is an excellent result that confirms Commercial Eyes’ reputation as the foremost pharmacovigilance and medical information provider in the region.


Oracle Argus

Commercial Eyes has invested significantly into technology, allowing high volume safety processing in-house and fully functional remote working services

Our team is proud to offer Oracle Argus, an industry leading, fully validated E2B (R3) compliant safety database. This enables quality and efficiency in processing, analysing and reporting adverse event cases originating in pre-and-post-market drugs, biologics, vaccine, devices and combination products.

Commercial Eyes can provide rapid set-up of services removing the cost and delay of implementing a compliant pharmacovigilance system in-house.

The pharmacovigilance team can provide a comprehensive service including

Management of local and global PV Systems

Support for clinical trial and post-marketing surveillance

Coverage of all regulatory requirements for pharmacovigilance, device vigilance and consumer

ISCR management, medical review, signal detection and aggregate reports compilation

RMP and ASA development

Preparation of safety database exchange agreements

Sponsor representation as the health authority contact person and qualified person for pharmacovigilance in AU & NZ

Inspection readiness activities including implementation of internal and partner PV audits

Lorenza Ricacho

Lorenza Ricacho

Our Pharmacovigilance team provides a comprehensive and ISO accredited service across 20 jurisdictions in Asia-Pacific, Canada, the EU and The United States.

Quality is important to us

Our processes are supported by our well-established ISO accredited quality management framework to ensure process efficiency and optimal outcomes

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