What is the difference between an AE and a serious AE?

An adverse event (AE) is any untoward occurrence associated with product use, regardless of causality or seriousness . A serious adverse event (SAE) meets specific regulatory criteria, which may include death, life-threatening experiences, inpatient hospitalization, persistent or significant disability, or congenital anomalies. The exact criteria for what constitutes "serious" vary by product category. Only SAEs typically trigger mandatory expedited reporting to regulatory authorities.

Who can report an adverse event?

Anyone can report: consumers, patients, caregivers, healthcare providers, manufacturers, distributors, retailers, or researchers. However, manufacturers have independent mandatory reporting obligations regardless of who first reports to them. Voluntary consumer reporting through FDA's MedWatch program does not eliminate a manufacturer's legal duty to report serious adverse events.

What are the minimum elements for a valid AE report?

The minimum elements are: an identifiable patient, an identifiable reporter, a suspect product, and an adverse event description. Even incomplete reports meeting these four criteria should be submitted within regulatory timelines, with follow-up reports providing additional information as it becomes available.

How should manufacturers submit an adverse event report?

Manufacturers typically submit mandatory reports through FDA’s ESG Gateway, the Safety Reporting Portal, or other designated channels, using appropriate forms such as MedWatch 3500A. The specific submission method and form may vary by product category. Timelines range from 5 to 30 days depending on product type and event severity.

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SafetyCall International Named a Minnesota Star Tribune Top Workplace for the 16th Time

June 15, 2026

For the 16th time, SafetyCall International has been named a Minnesota Star Tribune Top Workplace.

Behind everything we do, there are real people. A real person answers every call that comes into our contact center. A real person reviews every adverse event case. A real person helps a client navigate a regulatory question they've never faced before. That has been true since we opened our doors in 2004, and it remains true today.

Our people are exactly who this recognition comes from. They show up every day to care for our clients and their consumers, and this award tells us they feel cared for in return.

The Top Workplace recognition is based solely on employee feedback, gathered and analyzed by Energage, an independent firm specializing in employee engagement and retention. This isn't a nominated award or a panel decision, just our team's honest experience of working here.

Knowing that over 300 people across SafetyCall and Pet Poison Helpline, a division of SafetyCall International, chose to say this is a good place to work is something we are incredibly proud of.

"Being named a Top Workplace 16 times is a recognition we are incredibly proud of—it is a reflection of the people who make SafetyCall what it is. What I find most meaningful is that this recognition comes directly from our team. It shows that the culture we've worked hard to build and maintain, one where people feel respected, supported, and genuinely valued, is something our employees actually experience every day. I'm incredibly proud of every person on our team who contributes to it." said Kelly Sioris, PharmD, President and Chief Operating Officer of SafetyCall International.

This honor reflects the collective efforts of our team members who work together to deliver exceptional care to our clients and their customers. Thanks to their dedication, we continue advancing our mission to make the world a safer place.

About SafetyCall International

SafetyCall International is a multidisciplinary health care practice that provides manufacturers with adverse event management, regulatory reporting, post-market surveillance, and consulting services. It operates the world's largest 24/7 human and animal adverse event call center, providing clients and their customers with immediate, around-the-clock access to trusted health, safety and medical information. As nationally recognized experts in the collection and interpretation of spontaneously reported incident data, the professional staff has managed more than 4 million product incident cases in the past 40 years, significantly impacting product safety worldwide. SafetyCall® also operates Pet Poison Helpline, a 24/7 animal poison control service for pet owners and veterinary professionals. For more information, visit safetycall.com.