Associate Director, Drug Safety job in Bethesda at Technical Resources International
Technical Resources International

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.

Recommended Skills

• Ich Guidelines
• Good Clinical Practices (Gcp)
• Pharmacovigilance
• Medicines And Healthcare Products Regulatory Agency (Mhra) Guides
• Reports
• Drug Development

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