SafetyCall International

1. © 2004 SafetyCall International PLLC. All rights reserved. All trademarks herein are property of SafetyCall, PLLC. All rights, title, and interest in and to all specifications, ideas and
concepts contained herein shall at all times be and remain vested in SafetyCall. Any persons with access to this document shall not retain, use or disclose any of such work
product without SafetyCall’s prior written consent.
SafetyCall International, PLLC

2. 2
Our mission is to provide our clients and their customers
immediate access to clear and trusted health, safety, and
medical information 24/7. As the market leader in adverse
event management and post-market surveillance services, we
actively enhance and promote product safety and facilitate
complete and accurate regulatory reporting.
Mission Statement

3. 3
•Over 25 years of experience in Adverse Event Management and
product safety
•World largest provider of Adverse Event Management services to
Industry
•Nearly 2 million consumer/institutional product incidents
managed
•Nationally recognized as authoritative and credible experts in the
area of Adverse Event Management, post-market surveillance, and
product stewardship
Our Professional Experience

4. 4
Three Core Services:
•24/7 Human and Animal Adverse Event Management
•SafetyCall Consulting Group
•24/7 Pet Poison Helpline
™
Services

5. 5
•Animal Health and Veterinary Products
•Ag-Chem
•Cosmetics and Beauty Aids
•Food Products
•Household Consumer Products
•Industrial Chemicals
•Institutional Products
•Nutritional and Dietary Supplements
•Pharmaceuticals (OTC and Rx)
Markets Served

6. 6
Formal affiliation with the University of Minnesota
•Teaching
•Service
•Research
•Policy Development
•Advocates for Sound Science in Regulatory Decision Making
Academic & Scholarly Activities

7. 7
Entire senior management team comprised of experts with
front line experience in patient care and direct client service
Executive Management
Leo Sioris, PharmD
CEO & Sr. Clinical Toxicologist
Rick Kingston, PharmD
President, Regulatory/Scientific Affairs &
Sr. Clinical Toxicologist
Dean Filandrinos, PharmD
VP, Operations & Sr. Clinical Toxicologist
John Gualtieri, PharmD, CSPI, MT(ASCP)
VP, Informations Systems and
Pharmacovigilance &
Sr. Clinical Toxicologist
Lynn Hovda, BS, RPh, DVM, MS, ACVIM
Veterinary Medical Director
Steve Borron, MD, MS, FACEP, FACMT
Medical Director

8. 8
Case Management
•A single source health care provider for managing both animal and human
allegations or reports of product related adverse events
•Highly trained professional staff providing case management and advice 24/7
to consumers or their health care providers on behalf of our corporate clients
•Front line toxicologists 24/7
•On-Call back-up senior clinicians across all medical disciplines
•Primary “Client Liaison” facilitating communications between our
respective organizations
•High level case reviews
24/7 Adverse Event Management Service

9. 9
Regulatory Reporting
•Provide timely and complete adverse event regulatory reports
involving EPA registered products, drugs regulated by the FDA,
or products regulated under TSCA
•FIFRA 6(a)2 Single Incident Reports and Quarterly Aggregated
Data
•PMRA Reporting
•Dietary Supplement FDA Reporting
24/7 Adverse Event Management Service

10. 10
•Regulatory compliance
•Industry to government interface
•Product risk assessment, management
•Risk communication to your stakeholders including,
consumers, NGO’s, regulators, suppliers and legislators
SafetyCall Consulting

11. 11
A division of SafetyCall, Pet Poison Helpline (PPH) is an
international, 24-hour service available to pet owners and
veterinary professionals requiring assistance with a
potentially poisoned pet.

Pet Poison Helpline™

12. 12
•We recently ranked #3 in the small business category by the
Star Tribune as a Top Workplace in the Twin
Cities metro.
•The Star Tribune’s Top Workplaces recognizes the
most progressive companies in the Twin Cities
metro based on employee opinions about
company leadership, career opportunities,
workplace flexibility, compensation and benefits.
SafetyCall International & Pet Poison Helpline™
Awarded Top Workplaces 2010

13. © 2004 SafetyCall International PLLC. All rights reserved. All trademarks herein are property of SafetyCall, PLLC. All rights, title, and interest in and to all specifications, ideas and
concepts contained herein shall at all times be and remain vested in SafetyCall. Any persons with access to this document shall not retain, use or disclose any of such work
product without SafetyCall’s prior written consent.
SafetyCall International, PLLC
Please contact us!
[email protected]
866-327-7282
www.safetycall.com