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User:Grika/SafetyCall International

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SafetyCall International
Company typeProfessional Limited Liability Company (PLLC)
IndustryHealth care
GenreSenior services
FoundedBloomington, Minnesota, 2001 (2001)
FounderLeo Sioris, Rick Kingston, John Gualtieri, Dean Filandrinos, Lynn Hovda and Stephen Borron
Headquarters,
Number of locations
1
Area served
World-wide
Key people
Leo Sioris, PharmD (CEO); Rick Kingston, PharmD (President Scientific and Regulatory Affairs); Justine A. Lee, DVM, DACVECC, Associate Director of Veterinary Services
Servicesadverse event management, product safety information, adverse event data analysis, adverse event regulatory reporting, consulting, drug information services
Number of employees
80 (2011)
DivisionsPet Poison Helpline www.petpoisonhelpline.com
Website[1]

SafetyCall International is a Minnesota company involved with Adverse Event Management and Post-Market Surveillance Services to industry. They maintain an around-the-clock support staff of clinical, medical, and veterinary toxicologists, pharmacists, nurses, veterinarians and certified veterinary technicians, physicians, poison information providers and basic science toxicologists and maintain academic affiliation with the University of Minnesota in multiple collegiate units. SafetyCall is licensed with various Boards of Medicine, Veterinary Medicine and Pharmacy.

SafetyCall authored the guidance document when the joint Industry/EPA committee on 6(a)(2) reporting met to design a national voluntary incident reporting format. SafetyCall also has a consulting practice that augments existing company resources to help satisfy new and evolving requirements.

The postmarketing surveillance includes various agency reporting:

  • EPA FIFRA 6(a)(2) mandatory reporting
  • CPSC: TSCA and FHSA reporting and record keeping
  • FDA: Drug and medical device mandatory reporting
  • FDA: Dietary Supplement and Non-Prescription Drug Consumer Protection Act compliance
  • PMRA: The Pest Control Products Act

Industries Served

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