SafetyCall International
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SafetyCall International Presentation Transcript

  • 1. SafetyCall International, PLLC
  • 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.
    • 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.
    • Three Core Services:
      • 24/7 Human and Animal Adverse Event Management
      • SafetyCall Consulting Group
      • 24/7 Pet Poison Helpline ™
    Services
  • 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.
    • Formal affiliation with the University of Minnesota
      • Teaching
      • Service
      • Research
      • Policy Development
      • Advocates for Sound Science in Regulatory Decision Making
    Academic & Scholarly Activities
  • 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.
    • 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.
    • 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.
      • 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.
    • 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.
    • 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. SafetyCall International, PLLC Please contact us! [email_address] 866-327-7282 www.safetycall.com