Core Service
Pharmacovigilance
How Does Tanner Pharma Support Pharmacovigilance Requirements?
Effective pharmacovigilance oversight ensures global and country‑specific safety reporting requirements are continuously monitored and met. This requires defined safety governance, clear reporting pathways, and documented processes to support timely adverse event communication in line with ICH and local regulatory expectations.
Tanner Pharma coordinates effective pharmacovigilance processes across its access programs and clinical trial projects.
We monitor applicable PV requirements and oversee spontaneous adverse event reporting, ensuring that safety information received through operational activities is documented and communicated to sponsor PV teams or designated vendors within defined timelines according to the Safety Data Exchange Agreement.
Our Pharmacovigilance Capabilities
Continuous monitoring of applicable global pharmacovigilance regulations
Coordination of spontaneous adverse event reporting to sponsor PV teams or designated PV vendors
Safety event reporting according to terms under Safety Data Exchange Agreements
Compliance with ICH guidelines and country-specific safety reporting requirements
All safety reporting processes are defined within a Safety Data Exchange Agreement.