How a strong postmarketing surveillance partnership protects your consumers, your program, and your business
The terms you’ll see in this article
ICSR (Individual Case Safety Report) — the formal record of an adverse event submitted to a regulatorPADER / PSUR — periodic aggregate safety reports required for drugs and medical devices
MedWatch — the FDA’s voluntary and mandatory adverse event reporting system
PSMF (Pharmacovigilance System Master File) — the document describing your company’s pharmacovigilance system
MoCRA — Modernization of Cosmetics Regulation Act of 2022, governing cosmetic adverse event reporting and serious adverse event reporting
Adverse event management protects both public health and your business. When a consumer or patient experiences a reaction to your product, federal and international regulations require a response within specific timelines. But the companies that navigate this well understand something important: compliance is the floor, not the ceiling. A well-built postmarketing surveillance program is how you identify safety signals early, prevent small issues from becoming larger ones, and demonstrate, through documented practice, that your organization takes product safety seriously.
The obligation applies across product categories and regulatory frameworks. Whether your products are regulated by the FDA, EPA, CPSC, Health Canada, or other agencies, the expectation is the same: build a program that finds every qualifying event, documents it accurately, and reports it on time, every time.
How prepared is your adverse event program?
Use SafetyCall’s Adverse Event Program Self-Assessment to identify potential gaps in your intake, documentation, reporting, follow-up, and vendor oversight processes.
Why Compliance Gaps Develop
What makes adverse event compliance genuinely difficult is that the gaps regulators find are rarely the result of companies not caring. They develop quietly, and they often only become visible during an inspection, when the cost of correction is highest.
Written procedures that seemed sound when they were drafted may have drifted from current regulatory definitions. Vendor relationships that were never formally overseen have introduced errors that the responsible company is now accountable for. And inconsistent follow-up procedures, whether from unclear ownership across departments or from processes that were never formally documented, leave gaps that are hard to see from inside the program.
These are systemic issues. They are hard to see from inside a program. And across every regulated product category, they show up with enough consistency that regulatory authorities have made them a focus of inspection activity.
What Regulators Consistently Expect
Across product categories and agencies, the fundamentals of a compliant adverse event program are consistent. Regulatory authorities expect written procedures that align with regulatory definitions, timely submission of reportable events, documented follow-up, and meaningful oversight of any vendor or contractor performing safety functions on your behalf.
A challenge for companies with a diverse product portfolio is that the specific timelines and reporting pathways differ by product type and agency. Dietary supplements and cosmetics carry 15 business day serious adverse event reporting requirements under DSHEA and MoCRA respectively. This reporting obligation applies to all responsible persons regardless of company size. (MoCRA’s small business exemption applies only to a separate requirement — cosmetic facility registration and product listing — and doesn’t extend to serious adverse event reporting.)
Pharmaceutical products operate on 15 calendar day timelines under 21 CFR 314.80. Medical devices carry varying timelines under 21 CFR 803. Pesticide products regulated by the EPA carry their own incident reporting obligations. Health Canada operates parallel frameworks for products sold in Canada.
What is consistent across all of them is the underlying expectation: your program needs to be built to find and report every qualifying event, and to do so on time. The triggering event is receipt of the report, not when a case enters your internal tracking system.
The Four Areas Where Programs Most Often Fall Short
Based on what regulators cite and what well-run compliance programs have learned from experience, four areas account for most adverse event program deficiencies.
Written procedures that conflict with definitions. Regulators review SOPs in detail. A procedure that defines “serious adverse event” differently from the applicable statute, or that omits required follow-up steps, creates a compliance gap on paper before a single event is ever reported. These procedural misalignments are among the most commonly cited issues across inspections.
Missed or late reports (the #1 cause of FDA 482 observations). Reporting timelines begin at initial receipt of a report, not when it reaches a regulatory team or enters a case management system. Companies that rely on manual intake, inconsistent channel coverage, or unclear escalation paths are the most vulnerable to late reporting. This is especially true for organizations managing growing product portfolios or increasing consumer contact volume.
Inconsistent follow-up. Companies are expected to make a reasonable attempt to follow up with reporters to obtain additional case information. The most common failure is not doing this consistently, whether because ownership is unclear, because the process sits across multiple departments without clean handoffs, or because follow-up procedures were never formally documented in the first place. Each of these creates the same inspection exposure.
Choosing the right partner for AE functions. When a third party performs adverse event functions on your behalf, you remain fully responsible for their compliance. Errors made by a contractor, whether missed cases, invalid rejections, or late submissions, are treated as your organization’s compliance failures. The quality of that relationship depends entirely on the partner’s clinical depth, regulatory experience, and operational consistency. A partner with 40 years of experience in this role brings a fundamentally different level of reliability than one standing up these capabilities for the first time.
Why Partnership Matters
Building a compliant adverse event program is not a one-time project. It requires ongoing medical review, consistent documentation, a process for managing and resolving deviations, and the operational infrastructure to handle incoming reports at any hour, across any channel.
For most organizations, that is genuinely difficult to build and maintain internally, particularly when the core team’s focus is product development, quality, or operations rather than post-market regulatory compliance and product safety. A lean regulatory team can establish the right procedures and oversight, but without clinical staff available to review potentially reportable events, cases can wait for the next business day to be evaluated. That is precisely the gap regulators look for.
The right partner does not replace your team’s judgment. It extends your capacity and makes the clinical evaluation that good adverse event management requires available at scale, across every channel your consumers use to reach you.
How SafetyCall Approaches This Work
SafetyCall International works with companies across 12 regulated industries to build adverse event programs that hold up to regulatory scrutiny. Our practice is the only one triple-licensed in medicine, pharmacy, and veterinary medicine, which means every qualified case we handle is assessed by a licensed physician, pharmacist, nurse, or veterinarian. Not an intake coordinator working from a script.
Signal detection in pharmacovigilance A compliant program does more than report individual cases. Signal detection — the systematic review of adverse event data to identify emerging safety trends — is increasingly an inspection focus. SafetyCall’s medical reviewers maintain ongoing case-trend evaluation across your portfolio.
We operate a 24/7 medical contact center. Our written procedures are built around regulatory definitions, not approximations of them. And with over 40 years of experience managing millions of adverse events across industries from dietary supplements to pesticides to animal health products, we bring a depth of regulatory context that comes from working at the center of this field for a long time.
Whether you are building internal capabilities and want to understand what a well-structured program looks like, or you are looking for a partner to manage your adverse event program directly, the goal is the same: a compliant, well-defined system that protects your consumers and patients and gives your team confidence when regulators ask questions.
Two ways to get started
Use our Adverse Event Program Self-Assessment to evaluate where your current program stands against regulatory expectations. It’s a practical starting point for any team looking to identify gaps before an inspection or retailer audit finds them first.
Enter your email below, and we’ll send the self-assessment directly to you.
Or, if you’re ready to talk through your specific situation, reach out to schedule a consultation. We’ll discuss your product categories, regulatory obligations, and what a well-built adverse event program looks like for your business.
www.safetycall.com | 1-952-830-7097 | [email protected]
