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Associate Director, Drug Safety

Company: Technical Resources International
Location: Bethesda
Posted on: January 16, 2022

Job Description:

Responsibilities:

  • Provides strategic, supervisory and clinical direction in the area of drug safety and pharmacovigilance for all company projects, while maintaining compliance with corporate policies and regulatory requirements.
  • Provides medical and regulatory review for adverse event reports (ICSR, PSUR, IND) and protocols in compliance with international and domestic regulations and guidelines.
  • Develops and reviews Safety and PVG SOPs, Operational plans, System Validations as per the regulatory standards and client specifications.
  • Manages the Drug Safety Teams assuring that these are properly functioning consistent with the TRI Safety policies and project timelines.
  • Identifies opportunities for process efficiency through coordination with management quality teams.
  • Participates in FDA and other regulatory meetings as required. Providing metrics and Root-cause analysis to the FDA & EMEA and MHRA comments.
  • Prepare Project plans with adoptability to accommodate regulatory changes and other study specific scientific updates.
  • Develops new programs and initiatives, and assists in the evaluation and development of new business concepts.
  • Provide training to safety team on safety data management, AE reporting, patient medical records and physician correspondence during all phases of drug development (Phase I- IV).
  • Work in collaboration with the Medical Monitors, Data Managers, Business Analysts, and Regulatory and Clinical operations teams to manage regulatory timelines in delivering client products as per the contract requirements. Requirements:
    • Medical degree (RN, MD, or DO), PharmD or Ph.D. with greater than 10 years of relevant work experience in the area of Safety/Human Subject Protection
    • Requires extensive knowledge of safety processes, audit practices, governing safety legislation and regulations
    • Requires knowledge of applicable global, regional and local regulatory requirements; i.e. Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
    • Demonstrated experience managing large drug safety teams

Keywords: Technical Resources International, Bethesda , Associate Director, Drug Safety, Executive , Bethesda, Maryland

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