PHARMACOVIGILANCE/SAFETY COMPLIANCE
Kohut

PERSONAL PROFILE

  • 30 years of experience in pharmacovigilance, specializing in establishment and optimization of
    inspection-ready global pre- and post-marketing PV function. Expertise in large and small pharma companies,
    including PV operations, cross-functional integration, compliance, safety data exchange agreements, outsourcing (vendor selection and management), signal detection and management, benefit-risk assessment/management, and safety governance.

EXPERTISE

Pharmacovigilance; SOPs; Vendor and Safety Database Selection and Management; Safety Signal/Risk Detection and Management; Safety Governance; PV Regulatory Compliance, Report Preparation, and Management; Global PV Operational Assessment, Strategy, and Implementation; Cross-functional Integration of PV; Risk Management Plans (REMS/Core/EU RMPs); Safety Data Exchange Agreements; Safety Management Plans; PV Audits/Inspections; and PV Curriculum and Training for Rx and OTC Drugs.

Member of US FDA/industry working group for the development of ICH documents on clinical safety (E2A, E2B, E2C, E2CR2). Served as Chair of the Clinical Safety Surveillance Committee of PhRMA (1997-2000).

BS, Pharmacy, Rutgers University; Doctor of Pharmacy, Philadelphia College of Pharmacy and Science.

PROFESSIONAL EXPERIENCE

President, JM Sills Consulting LLC
Expertise in global pharmacovigilance (PV) and safety risk management pre- and post-marketing, including PV and safety risk management operational strategy, implementation and optimization, signal detection/management, risk management plans, regulatory report preparation/management, PV inspection preparation/support, PV audits, and training. Product experience includes Rx-to-OTC switch, biologics, and dietary supplements. Built two PV departments (hired staff and developed operational infrastructure).

Vice President and Head, Global Pharmacovigilance, The Medicines Company
Led global pharmacovigilance department responsible for all pharmacovigilance activities related to development and marketed pharmaceutical and device products: safety data handling and reporting, training and compliance, signal detection and benefit/risk evaluation, and safety risk management. Chaired Global Safety Committee, and core member of Global Labeling Committee, Protocol Development Committee, and Global Integrity Oversight Committee.

VP/Global Head, Safety Risk Detection and Management, Novartis Pharmaceuticals Drug Safety and Epidemiology

  • Responsible for oversight of global safety risk management program, central signal detection group (automated data mining), and Safety Intelligence function.
  • Centralized automated signal detection function, including redesigning process, and hiring and training new staff.
  • Enhanced compliance tools and activities within Risk Management function.
  • Implemented new EU PV guidelines on risk management systems and signal detection.
  • Drove strategic development and innovation of methodology, technology, processes, training, and tools for medical safety activities (signal detection and evaluation, and safety risk management).
  • Shaped regulatory safety policy and strategy through intelligence activities. Led implementation of proactive safety risk management process, including integration of drug safety within clinical project teams.
  • Created role responsible for lifecycle management of safety profile, as well as Safety Management Teams, Medical Safety Review Board, and Risk Management Plan process.
  • Established global safety risk management program, including policies, procedures, training, templates, compliance tracking, and RMP project management.
  • Implemented a Risk Management Plan Manager role to support Safety Management Teams in preparing and responding to regulator inquiries/comments, and tracking Risk Management Plans.
  • Developed pre-marketing risk management plan template and processes. Implemented automated data mining tool (Empirica Signal), as well as a tool and process for signal management.
  • Designed and implemented an electronic tool and central process for managing custom MedDRA queries.
  • Established a template and process for Organ Safety Guidelines in clinical development, as well as a Hepatotoxicity Guideline.

 

VIEW ALL EXPERTISE

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