Associate Director, Drug Safety
Company: Technical Resources International
Posted on: January 16, 2022
- 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
- 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
- Manages the Drug Safety Teams assuring that these are properly
functioning consistent with the TRI Safety policies and project
- 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
- Prepare Project plans with adoptability to accommodate
regulatory changes and other study specific scientific
- 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
Didn't find what you're looking for? Search again!