Pharmacovigilance work rarely makes headlines when it goes well. A properly processed safety case, filed on time, in the right format, to the right authority, is simply part of the background operation of a clinical trial or a marketed product. It only becomes visible when something goes wrong — a missed reporting deadline, an inconsistent case assessment, or a database that cannot produce a clean audit trail during an inspection. Because of this, sponsors selecting among pharmacovigilance companies are generally better served by looking at specific operational signals rather than general claims of expertise.
Safety Database Validation: The Starting Point
Every pharmacovigilance operation depends on a safety database to capture, process, and track adverse event cases. Like an EDC system, this database needs to be validated and subject to the same kind of controls that apply to any electronic record supporting a regulatory submission — controlled access, an audit trail that reconstructs who changed what and when, and documented evidence that the system performs as intended.
A database that has not been properly validated creates risk well beyond a single case. If the underlying system’s integrity is questioned during an inspection, every case processed through it may need to be reviewed again, which can be far more disruptive than the original validation work would have been. Sponsors are generally advised to ask a prospective PV partner for documentation of their safety database’s validation status rather than accepting a general assurance of compliance.
ICSR Processing Accuracy and Reporting Timelines
An Individual Case Safety Report (ICSR) documents a single adverse event case, and how accurately it is assessed has direct regulatory consequences. Under ICH E2A, a serious adverse event is one that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability or incapacity, causes a congenital anomaly or birth defect, or qualifies as an important medical event based on medical and scientific judgment. And a serious, unexpected reaction that is suspected to relate to the product becomes a SUSAR, triggering expedited reporting obligations.
In jurisdictions with 7- and 15-day expedited reporting requirements, qualifying fatal or life-threatening cases may require reporting within 7 calendar days, while other reportable serious and unexpected cases may require reporting within 15 calendar days, subject to the applicable regional rules and reporting clock.
Meeting these timelines depends on more than administrative speed; it depends on a PV team correctly and consistently assessing seriousness, causality, and expectedness for each case, since a misclassified case can either trigger an unnecessary expedited report or, more seriously, delay one that was actually required. Processing accuracy at this stage, including proper case data entry for electronic transmission in the ICH E2B(R3) format, is one of the more concrete ways to compare PV providers against each other.
Where Tigermed’s PV Structure Fits This Picture
Sponsors comparing pharmacovigilance services generally want to understand both the scale of a provider’s operation and how its case-processing work is organized. Tigermed’s current PV service profile lists 300+ global partners, 200+ global PV experts, and 2,000+ project experience, while its 2025 results report a global PV team of more than 190 members covering China, Europe, the U.S., Japan, South Korea, Southeast Asia, and other regions. The company’s PV offering spans both clinical trial safety operations — including safety management plan development and DSUR support — and post-marketing services such as case management, PSUR drafting, and signal detection.
Tigermed’s 2024 interim results marked the establishment of its first local pharmacovigilance team in the United States, while subsequent company updates show that its global PV organization has since expanded across additional regions, and its 2023 acquisition of Marti Farm added a European CRO with dedicated pharmacovigilance, clinical operations, and regulatory affairs experience. This kind of regional buildout is relevant to sponsors running multi-region programs, since local PV presence generally supports faster literature screening and case intake in a given jurisdiction’s own language and regulatory context.
Regulatory Submission Track Record
Beyond individual case processing, a PV provider’s track record with aggregate safety reporting — including Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs) — offers another useful comparison point. These reports require a PV team to synthesize accumulated safety data into a coherent risk-benefit narrative that regulators will scrutinize closely, which is a different skill set from processing individual cases quickly.
Tigermed’s reported business activity provides additional context: in the first half of 2024, its PV team signed 80 new projects and gained 106 new customers, while the company reported 255 new PV projects and 189 new clients for the full year 2025. Figures like these indicate sustained demand for Tigermed’s PV services, though sponsors should still ask about experience specific to their own product type, safety workload, and target regulatory agencies rather than relying on aggregate project volume alone.
Inspection History and What It Signals
A pharmacovigilance provider’s own inspection and audit history is often the clearest evidence of whether its stated processes hold up under scrutiny. Health authority inspections of PV systems typically examine case processing timelines, database integrity, and whether a company’s Pharmacovigilance System Master File accurately reflects its actual operations.
Tigermed’s broader quality assurance function, which the company describes as independent of clinical operations, supports audit services including pharmacovigilance-related reviews alongside GCP, GLP, and GMP audits.
Sponsors evaluating any PV vendor are generally advised to ask directly about past health authority inspection outcomes and any resulting corrective action plans, since this history — more than a general compliance statement — indicates how a provider’s systems perform when examined by a regulator rather than only by the sponsor itself.
Weighing These Signals Together
No single factor listed here fully substitutes for the others. A well-validated database does not guarantee accurate case assessment, and a strong submission volume does not eliminate the need to check inspection history. Sponsors comparing pharmacovigilance companies are generally best served by requesting documentation across all four areas — database validation, case-processing quality metrics, submission history relevant to their product type, and past inspection outcomes — before finalizing a vendor decision.
Companies such as Tigermed, which report a multi-region PV team alongside an independent QA and audit function, illustrate one way these elements can be structured together. As with any safety-critical vendor decision, sponsors are advised to confirm current, product-specific experience directly with a provider before finalizing a selection.
