Drug Safety Specialist

Drug Safety Specialist Overview

• The Drug Safety Specialist is responsible for managing drug safety operations, ensuring compliance with regulatory standards, and maintaining high-quality safety reporting processes.
• This part-time, remote contract role offers flexibility with a 20-hour workweek and opportunities to contribute to impactful safety initiatives.
• Collaborate with cross-functional teams to ensure timely and accurate safety data collection and reporting.
• Perform activities aligned with FDA regulations, ICH/GCP guidelines, and company SOPs.
• Contribute to the preparation and review of safety reports and regulatory documents.
• Engage in professional development and maintain collaborative relationships with stakeholders.
• Support clinical teams with safety-related issues and participate in relevant meetings.
• Assist in the development and implementation of drug safety SOPs and processes.

Drug Safety Specialist Key Responsibilities & Duties

• Collect, assess, and process safety reports in compliance with ICH-GCP guidelines and regulatory requirements.
• Perform quality control reviews to ensure data accuracy and completeness in safety databases.
• Prepare and facilitate submissions of safety reports to regulatory authorities and partner organizations.
• Collaborate with medical monitors for MedDRA and WHO-Drug coding.
• Participate in the planning and preparation of adverse event sections for clinical protocols.
• Conduct safety database reconciliations with clinical databases for ongoing studies.
• Support safety-related audits and ensure compliance with GCP and ICH standards.
• Provide coverage for essential safety functions during non-business hours as needed.
• Participate in the development and management of Clinical Event and Data Monitoring Committees.

Drug Safety Specialist Job Requirements

• Bachelor’s degree in Nursing, Pharmacy, or Life Sciences is required.
• Minimum of 2 years of patient management or relevant clinical research experience; critical care experience preferred.
• 1-2 years of pharmaceutical safety reporting experience for entry-level specialists; 3-4 years for advanced specialists.
• Strong knowledge of FDA and ICH regulations and GCP guidelines is preferred.
• Proficiency in Microsoft Word, PowerPoint, and Excel is required.
• Excellent written and verbal communication skills with the ability to build collaborative relationships.
• Ability to assess risks and make timely, informed decisions independently.
• Willingness to travel up to 20% as required for the role.